CLASS II Device recall · Reported 23 Mar 2016 · FDA Enforcement Report

Product 47 consists of all product under product recalled

Zimmer Manufacturing is recalling Product 47 consists of all product under, distributed nationwide in the US. The recall was initiated on 11 Jan 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codeslot no.: 61890322 62213292 62215053 62277522 62402117 61921671 62207256 62212215 62241126 62251893 62268498 62281865 62396132 62402115 62024672 62176459 62210646 62215051 62221907 62241128 62241129 62266480 62277523 62402113 62402114 62406796 62202293 62218187 62255246 62281866 62354788 62396145 62406802 61882636 61890326 61942630 61943368 61957706 61957708 61957709 61968019 61983748 61983749 62109144 62109145 62143889 62163554 62173374 62176463 62188368 62197359 62197360 62197361 62204040 62204041 62204042 62204632 62204633 62204634 62207259 62210647 62210648 62213295 62221909 62221910 62226817 62233573 62238101 62241131 62241135 62241136 62241137 62241139 62241142 62241144 62241145 62251896 62251897 62251898 62251899 62251901 62255247 62266481 62266482 62277524 62284060 62352923 62358047 62383751 62383752 62383753 62383754 62386984 62386985 62402212 62402217 61882637 61885966 61889305 61976198 62147389 62170705 62191282 62197358 62199480 62199481 62210649 62210650 62218188 62218189 62218190 62236577 62236578 62241147 62251895 62258978 62260179 62260180 62352924 62358045 62388057 62402126 62402213 61890327 61968020 62170708 62188373 62207257 62207258 62226818 62241149 62241150 62251902 62258976 62268506 62383758 62383759 62396119 62396120 62396121 61980814 62170709 62202294 62202295 62236582 62258974 62260181 62260182 62352926 62358046 62383761 62396133 61976203 62170710 62176464 62191285 62193578 62221912 62226823 62241152 62250619 62251903 62265335 62354787 62396122 62396123 62403713 62406785 61885968 61980816 62167449 62198732 62202296 62218192 62241154 62266483 62354789 62389394 62389395 62402214 61919746 62170712 62207260 62226819 62226820 62251112 62265336 62383760 62402140 62406770 61882639 61980817 62167448 62218193 62266484 62396135 62403714 62406808 61882640 62199479 62233574 62258975 62396149 61980818 62238099 62354790 62402121 62406806 62221914 62402116 62255245 62402122 62268507 62406810 62188377 62258972 62260183 62402118 62183219 62193583 62354791 62406803 61815148 62080364 62154619 62180252 62193580 62193581 62226821 62226822 62241155 62241156 62251113 62268508 62316411 62383755 62383757 62396134 62402112 62406794 62402123 62213294 62215054 62396142 62406786 62354792 62406804 62233572 62406807 62163545 62395778 62202292 62241114 62198725 62226816 62241115 62268495 62389251 62389252 62198722 62218184 62268496 62395770 62406805 62218185 62277521 62395775 62406812 62395776 62281868

Quantity recalled30

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1145-2016
FDA event ID: 72900
Recalling firm: Zimmer Manufacturing, Mercedita, PR
Classification: Class II
Status: Terminated
Recall initiated: 11 Jan 2016
FDA classified: 12 Mar 2016
Reported: 23 Mar 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

11 Jan 2016	Recall initiated by company
12 Mar 2016	Classified by FDA	+61 days
23 Mar 2016	Published in enforcement report	+11 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

Product 47 consists of all product under product code: LPH and same usage: Item no: 611004022 MODULAR CUP 10 DEGREE LIN 611004428 MODULAR CUP 10 DEGREE LIN 611004628 MODULAR CUP 10 DEGREE LIN 611004828 MODULAR CUP 10 DEGREE LIN 611004832 MODULAR CUP 10 DEGREE LIN 611005028 MODULAR CUP 10 DEGREE LIN 611005032 MODULAR CUP 10 DEGREE LIN 611005628 MODULAR CUP 10 DEGREE LIN 611005632 MODULAR CUP 10 DEGREE LIN 611005828 MODULAR CUP 10 DEGREE LIN 611005832 MODULAR CUP 10 DEGREE LIN 611006028 MODULAR CUP 10 DEGREE LIN 611006032 MODULAR CUP 10 DEGREE LIN 611006228 MODULAR CUP 10 DEGREE LIN 611006232 MODULAR CUP 10 DEGREE LIN 611006428 MODULAR CUP 10 DEGREE LIN 611006432 MODULAR CUP 10 DEGREE LIN 611006628 MODULAR CUP 10 DEGREE LIN 611006832 MODULAR CUP 10 DEGREE LIN 611007028 MODULAR CUP 10 DEGREE LIN 612004626 MODULAR CUP 20 DEGREE LIN 612004628 MODULAR CUP 20 DEGREE LIN 612004828 MODULAR CUP 20 DEGREE LIN 612004832 MODULAR CUP 20 DEGREE LIN 612005028 MODULAR CUP 20 DEGREE LIN 612005032 MODULAR CUP 20 DEGREE LIN 612005628 MODULAR CUP 20 DEGREE LIN 612005828 MODULAR CUP 20 DEGREE LIN 612005832 MODULAR CUP 20 DEGREE LIN 612006028 MODULAR CUP 20 DEGREE LIN 612006032 MODULAR CUP 20 DEGREE LIN 610504428 MODULAR CUP NEUTRAL LINER 610504832 MODULAR CUP NEUTRAL LINER 610505028 MODULAR CUP NEUTRAL LINER 610505032 MODULAR CUP NEUTRAL LINER 610505632 MODULAR CUP NEUTRAL LINER 610505832 MODULAR CUP NEUTRAL LINER 610506032 MODULAR CUP NEUTRAL LINER 610506232 MODULAR CUP NEUTRAL LINER For use in total hip arthroplasty

Where it was distributed

US Nationwide Distribution

Nationwide

Questions about this recall

Why was it recalled?

As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.

Which lots are affected?

lot no.: 61890322 62213292 62215053 62277522 62402117 61921671 62207256 62212215 62241126 62251893 62268498 62281865 62396132 62402115 62024672 62176459 62210646 62215051 62221907 62241128 62241129 62266480 62277523 62402113 62402114 62406796 62202293 62218187 62255246 62281866 62354788 62396145 62406802 61882636 61890326 61942630 61943368 61957706 61957708 61957709 61968019 61983748 61983749 62109144 62109145 62143889 62163554 62173374 62176463 62188368 62197359 62197360 62197361 62204040 62204041 62204042 62204632 62204633 62204634 62207259 62210647 62210648 62213295 62221909 62221910 62226817 62233573 62238101 62241131 62241135 62241136 62241137 62241139 62241142 62241144 62241145 62251896 62251897 62251898 62251899 62251901 62255247 62266481 62266482 62277524 62284060 62352923 62358047 62383751 62383752 62383753 62383754 62386984 62386985 62402212 62402217 61882637 61885966 61889305 61976198 62147389 62170705 62191282 62197358 62199480 62199481 62210649 62210650 62218188 62218189 62218190 62236577 62236578 62241147 62251895 62258978 62260179 62260180 62352924 62358045 62388057 62402126 62402213 61890327 61968020 62170708 62188373 62207257 62207258 62226818 62241149 62241150 62251902 62258976 62268506 62383758 62383759 62396119 62396120 62396121 61980814 62170709 62202294 62202295 62236582 62258974 62260181 62260182 62352926 62358046 62383761 62396133 61976203 62170710 62176464 62191285 62193578 62221912 62226823 62241152 62250619 62251903 62265335 62354787 62396122 62396123 62403713 62406785 61885968 61980816 62167449 62198732 62202296 62218192 62241154 62266483 62354789 62389394 62389395 62402214 61919746 62170712 62207260 62226819 62226820 62251112 62265336 62383760 62402140 62406770 61882639 61980817 62167448 62218193 62266484 62396135 62403714 62406808 61882640 62199479 62233574 62258975 62396149 61980818 62238099 62354790 62402121 62406806 62221914 62402116 62255245 62402122 62268507 62406810 62188377 62258972 62260183 62402118 62183219 62193583 62354791 62406803 61815148 62080364 62154619 62180252 62193580 62193581 62226821 62226822 62241155 62241156 62251113 62268508 62316411 62383755 62383757 62396134 62402112 62406794 62402123 62213294 62215054 62396142 62406786 62354792 62406804 62233572 62406807 62163545 62395778 62202292 62241114 62198725 62226816 62241115 62268495 62389251 62389252 62198722 62218184 62268496 62395770 62406805 62218185 62277521 62395775 62406812 62395776 62281868

Where was it sold?

US Nationwide Distribution

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

70 other products · FDA event 72900

This product is part of a recall event; the main page for the event is Product 25 consists of all product under product recalled.

Reported	Class	Recall	Company	Reason	Where
23 Mar 2016	CLASS II	Product 25 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 48 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 12 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 31 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 29 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 52 consists of product recalled by Zimmer Manufacturing B.V	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 18 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 5 consists of all products under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 28 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 51 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 36 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 17 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 45 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 34 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 59 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 10consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 65 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 14 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 62 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 19 consists of all product recalled by Zimmer Manufacturing B.V	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 35 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 67 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 54 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 1 consists of all product under , product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 64 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 37 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 27 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 7 consists of all products under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 8 consists of all products under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 3 consists of all products under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 15 consists of all product recalled by Zimmer Manufacturing B.V	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 56 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 42 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 43 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 4 consists of all products under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 16 consists of all product under poduct recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 46 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 69 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 30 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 60 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 63 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 70 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 66 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 20 consists of all prod oct under poduct recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 22 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 13 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 71 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 40 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 49 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 26 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 41 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 32 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 9 consists of all product under HRS, and same usage recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 50 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 39 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 57 consists of all product recalled by Zimmer Manufacturing B.V	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 11 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 33 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 38 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 58 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 55 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 6 consists of all products under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 2 consists of all products product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 61 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 68 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 21 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 23 consists of all product recalled by Zimmer Manufacturing B.V	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 44 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 24 consists of all product under product recalled	Zimmer Manufacturing	Sterility	Nationwide
23 Mar 2016	CLASS II	Product 72 consists of all product recalled by Zimmer Manufacturing B.V	Zimmer Manufacturing	Sterility	Nationwide

More recalls from Zimmer Manufacturing

All 90

Reported	Class	Recall	Company	Reason	Where
25 May 2016Device	CLASS II	Periarticular plating system, cancellous bone screw recalled	Zimmer Manufacturing	Sterility	Nationwide
25 May 2016Device	CLASS II	Mini MagnaFx Cannulated Screw Fixation System Small recalled	Zimmer Manufacturing	Sterility	Nationwide
25 May 2016Device	CLASS II	Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping recalled	Zimmer Manufacturing	Sterility	Nationwide
25 May 2016Device	CLASS II	Herbert Cannulated Bone Screw System, Bone Screw Dia recalled	Zimmer Manufacturing	Sterility	Nationwide
25 May 2016Device	CLASS II	Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping recalled	Zimmer Manufacturing	Sterility	Nationwide

Other Hip & Knee Implants recalls

All 3,097

Reported	Class	Recall	Company	Reason	Where
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
26 Aug 2026Device	CLASS II	Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation	Kico Knee Innovation	Device Malfunction	19 states
26 Aug 2026Device	CLASS II	Veritas Standard Reverse Total Shoulder Veritas Standard recalled	restor3d	Device Malfunction	Nationwide
19 Aug 2026Device	CLASS II	Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled	Waldemar Link GmbH & Co. KG (Mfg Site)	Other	IN
12 Aug 2026Device	CLASS II	U2 Total Knee System Femoral offset bushing recalled	United Orthopedic	Device Malfunction	Nationwide