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

Product 30 consists of all product under product recalled

Zimmer Manufacturing is recalling Product 30 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.: 61982436 61867365 61886667 61886668 61820722 61897702 61977095 61799436 61934575 61828057 61982437 61828048 61934576 61798403 61906719 62031688 62197641 61663372 61828049 61886669 61828050 62031689 61828053 62106374 61828054 62033051 62197643 61828055 61906715 61982438 61867334 61977096 61927725 61784953 61867368 61849821 61849827 61906712 62124274 62120943 61785930 61771006 61826981 61895080 61902197 61827363 61888704 61895083 62255904 61902213 61990124 61753044 62271887 61850459 61778818 61778840 61827350 61827352 61827355 61853069 61865454 61865455 61888705 61895087 61897708 61897709 61897711 61900062 61941016 61941017 61958817 61990133 62127925 62130793 62130794 62241680 62255912 62255914 62255920 62271894 61902217 61958146 62271889 61958147 61955869 62105421 61860644 61888706 61937605 370531 61853081 61870427 62230186 61777469 61923868 61940612 61940613 370989 61853082 61955870 61890945 61930189 61859417 61923869 61788809 61829108 370516 61860640 61874946 370515 370959 370956 61843251 61937601 62105422 371015 61895079 61788813 61849271 371014 370517 61860668 61869716 61874978 370990 370923 61891507 371071 61902208 370955

Quantity recalled3500

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-1128-2016
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: Surgical Instruments

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 30 consists of all product under product code: KTT and same usage: Item no: 118100527 FREE-LOCK LAG SCREW, 12.7 118100535 FREE-LOCK LAG SCREW, 12.7 118100540 FREE-LOCK LAG SCREW, 12.7 118100542 FREE-LOCK LAG SCREW, 12.7 118101022 FREE-LOCK LAG SCREW, 12.7 118101025 FREE-LOCK LAG SCREW, 12.7 118101027 FREE-LOCK LAG SCREW, 12.7 118101030 FREE-LOCK LAG SCREW, 12.7 118101032 FREE-LOCK LAG SCREW, 12.7 118101035 FREE-LOCK LAG SCREW, 12.7 118101037 FREE-LOCK LAG SCREW, 12.7 118101040 FREE-LOCK LAG SCREW, 12.7 118101042 FREE-LOCK LAG SCREW, 12.7 118101045 FREE-LOCK LAG SCREW, 12.7 118101047 FREE-LOCK LAG SCREW, 12.7 118101052 FREE-LOCK LAG SCREW, 12.7 118101055 FREE-LOCK LAG SCREW, 12.7 118101057 FREE-LOCK LAG SCREW, 12.7 118101522 FREE-LOCK LAG SCREW, 15.8 118101525 FREE-LOCK LAG SCREW, 15.8 118101527 FREE-LOCK LAG SCREW, 15.8 118101530 FREE-LOCK LAG SCREW, 15.8 118101532 FREE-LOCK LAG SCREW, 15.8 118101547 FREE-LOCK LAG SCREW, 15.8 118109010 FREE-LOCK SUPRACOND TUBE/ 118109510 FREE-LOCK SUPRACOND TUBE/ 118113005 FREE-LOCK TUBE & SCP PLAT 118113006 FREE-LOCK TUBE & SCP PLAT 118113010 FREE-LOCK TUBE & SCP PLAT 118113504 FREE-LOCK TUBE & SCP PLAT 118113505 FREE-LOCK TUBE & SCP PLAT 118113506 FREE-LOCK TUBE & SCP PLAT 118113508 FREE-LOCK TUBE & SCP PLAT 118113510 FREE-LOCK TUBE & SCP PLAT 118113594 FREE-LOCK TUBE & SCP PLAT 118114005 FREE-LOCK TUBE & SCP PLAT 118114006 FREE-LOCK TUBE & SCP PLAT 118114008 FREE-LOCK TUBE & SCP PLAT 118114010 FREE-LOCK TUBE & SCP PLAT 118114012 FREE-LOCK TUBE & SCP PLAT 118114004 FREE-LOCK TUBE & SCP PLAT 118114008 FREE-LOCK TUBE & SCP PLAT 118114010 FREE-LOCK TUBE & SCP PLAT 118114012 FREE-LOCK TUBE & SCP PLAT 118114504 FREE-LOCK TUBE & SCP PLAT 118114505 FREE-LOCK TUBE & SCP PLAT 118114506 FREE-LOCK TUBE & SCP PLAT 118114508 FREE-LOCK TUBE & SCP PLAT 118114512 FREE-LOCK TUBE & SCP PLAT 118114594 FREE-LOCK TUBE & SCP PLAT 118114508 FREE-LOCK TUBE & SCP PLAT 118114512 FREE-LOCK TUBE & SCP PLAT 118114594 FREE-LOCK TUBE & SCP PLAT 118115004 FREE-LOCK TUBE & SCP PLAT 118115005 FREE-LOCK TUBE & SCP PLAT 118115006 FREE-LOCK TUBE & SCP PLAT 118115008 FREE-LOCK TUBE & SCP PLAT 118115094 FREE-LOCK TUBE & SCP PLAT 118113508 FREE-LOCK TUBE & SCP PLAT 118113506 FREE-LOCK TUBE & SCP PLAT 118113505 FREE-LOCK TUBE & SCP PLAT 118113504 FREE-LOCK TUBE & SCP PLAT 118113004 FREE-LOCK TUBE & SCP PLAT Product Usage: Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.

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.: 61982436 61867365 61886667 61886668 61820722 61897702 61977095 61799436 61934575 61828057 61982437 61828048 61934576 61798403 61906719 62031688 62197641 61663372 61828049 61886669 61828050 62031689 61828053 62106374 61828054 62033051 62197643 61828055 61906715 61982438 61867334 61977096 61927725 61784953 61867368 61849821 61849827 61906712 62124274 62120943 61785930 61771006 61826981 61895080 61902197 61827363 61888704 61895083 62255904 61902213 61990124 61753044 62271887 61850459 61778818 61778840 61827350 61827352 61827355 61853069 61865454 61865455 61888705 61895087 61897708 61897709 61897711 61900062 61941016 61941017 61958817 61990133 62127925 62130793 62130794 62241680 62255912 62255914 62255920 62271894 61902217 61958146 62271889 61958147 61955869 62105421 61860644 61888706 61937605 370531 61853081 61870427 62230186 61777469 61923868 61940612 61940613 370989 61853082 61955870 61890945 61930189 61859417 61923869 61788809 61829108 370516 61860640 61874946 370515 370959 370956 61843251 61937601 62105422 371015 61895079 61788813 61849271 371014 370517 61860668 61869716 61874978 370990 370923 61891507 371071 61902208 370955

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 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 47 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 Surgical Instruments recalls

All 3,809

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Device	CLASS II	Medline Convenience Kits: IV Start KIT recalled by Medline Industries	Medline Industries	Sterility	Nationwide
9 Sep 2026Device	CLASS II	Medline Convenience Kits containing BD ChloraPrep Clear recalled	Medline Industries	Packaging Defects	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: Open Heart Pack, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Medline convenience kits labeled as: GYN Robotic CDS, Medline Kit recalled	Medline Industries	Other	Nationwide
2 Sep 2026Device	CLASS II	Linvatec Genesys CrossFT Suture Anchor with Disposable Driver recalled	ConMed	Other	Nationwide