CLASS II Device recall · Reported 23 Mar 2016 · FDA Enforcement Report
Product 68 consists of all product under product recalled
Zimmer Manufacturing is recalling Product 68 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
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-1166-2016
- 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 68 consists of all product under product code: JDI and same usage: Item no: 787101360 VERSYS CEM/REV/CALCAR 13X 787101361 VERSYS CEM/REV/CALCAR 13X 787101362 VERSYS CEM/REV/CALCAR 13X 787101363 VERSYS CEM/REV/CALCAR 13X 787101560 VERSYS CEM/REV/CALCAR 15X 787101561 VERSYS CEM/REV/CALCAR 15X 787101562 VERSYS CEM/REV/CALCAR 15X 787101563 VERSYS CEM/REV/CALCAR 15X 787101760 VERSYS CEM/REV/CALCAR 17X 787101761 VERSYS CEM/REV/CALCAR 17X 787101761 VERSYS CEM/REV/CALCAR 17X For use in total or hemi hip arthroplasty
Where it was distributed
US Nationwide Distribution
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.: 61750613 61750614 61868570 61952541 62024610 62030924 62038337 62042578 62050967 62050968 62055953 62058544 62062916 62067900 62076933 62079992 62086045 62097029 62112166 62114833 62132264 62134027 62134028 62143844 62143845 62159824 62199401 62199402 62202245 62222764 62225719 62236534 62240268 62240781 62240783 62244343 62244344 62256020 62256021 62256022 62264272 62270718 62277491 62277507 62277508 62305949 62305950 62312493 62312494 62315892 62318764 62320156 62325567 62326096 62332923 62332924 62332925 62340037 62340038 61843322 61856105 61864096 61868571 62042579 62055955 62055956 62076934 62076936 62086043 62112165 62114834 62132263 62143842 62197213 62199403 62207226 62244341 62244342 62256025 62257216 62266494 62268559 62279449 62287353 62291944 62298295 62299092 62305947 62317922 62326097 62340039 62340040 62005387 62024613 62069014 62097031 62134029 62192539 62202246 62225718 62234467 62255228 62264273 62268560 62291945 62325568 62333495 61925004 62050965 62060670 62079989 62105186 62240782 62257142 62260131 62260132 62312495 62333989 61708135 62030925 62050969 62055958 62067899 62079993 62097032 62194662 62195516 62234471 62234473 62256023 62256024 62256026 62291946 62291947 62317132 62317134 62318765 62333493 62338822 62338823 62055957 62079990 62112164 62159826 62207227 62244345 62257141 62277509 62293488 62305948 62320159 62330766 62043457 62079987 62194661 62244346 62249022 62264274 62326098 370621 61964719 62005385 62058545 62105185 62266493 62317921 61846922 62062915 62143841 62240784 62270717 62317920 62326099 62340042 61658292 62244347 62347297
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 72900This product is part of a recall event; the main page for the event is Product 25 consists of all product under product recalled.
More recalls from Zimmer Manufacturing
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|---|---|---|---|---|---|
| Device | CLASS II | Periarticular plating system, cancellous bone screw recalled | Zimmer Manufacturing | Sterility | Nationwide |
| Device | CLASS II | Mini MagnaFx Cannulated Screw Fixation System Small recalled | Zimmer Manufacturing | Sterility | Nationwide |
| Device | CLASS II | Zimmer Plates and Screws (ZPS) Cortical Screw SelfTapping recalled | Zimmer Manufacturing | Sterility | Nationwide |
| Device | CLASS II | Herbert Cannulated Bone Screw System, Bone Screw Dia recalled | Zimmer Manufacturing | Sterility | Nationwide |
| Device | 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 |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |