Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM… — Class II medical device recall Z-1260-2014
Terminated recall by Zimmer, Inc., reported 2014-03-26, distributed nationwide. A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was
| Recall number | Z-1260-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-02-25 |
| Classified | 2014-03-20 |
| Reported by FDA | 2014-03-26 |
| Terminated | 2015-03-24 |
| Distributed | Nationwide (US) |
| Countries outside the US | AT, AU, CA, CH, CZ, DE, ES, FR, IN, JP, KR, LU, VE |
| Quantity | 3,638 units |
| Model numbers | 681600016, 681600019, 681600022, 681601016, 681602016, 681602022, 681603016, 681603019, 681604009, 681604011, 681604013, 681604016, 681604019, 681604022, 681605009, 681605019 |
Product
Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2/16M APOLLO PS TIB INS SZ2/22MM APOLL PS TIB INS SZ3/16MM APOLL PS TIB INS SZ3/19MM APOLL PS TIB INS SZ4/9MM APOLLO PS TIB INS SZ4/11MM APOLL PS TIB INS SZ4/13MM APOLL PS TIB INS SZ4/16MM APOLL PS TIB INS SZ4/19MM APOLL PS TIB INS SZ4/22MM APOLL PS TIB INS SZ5/9MM APOLLO PS TIB INS SZ5/19MM APOLL
Reason for recall
A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1260-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.