Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER… — Class II medical device recall Z-1261-2014
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-1261-2014 |
|---|---|
| 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 | 682000016, 682001011, 682001016, 682001022, 682001030, 682002011, 682002013, 682002016, 682002022, 682002030, 682003016, 682003022, 682003025, 682004013, 682004016, 682005011 |
Product
Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK TIB INSER SZ1-22MM AK CCK TIB INSER SZ1-30MM AK CCK TIB INSER SZ2-11MM AK CCK TIB INSER SZ2-13MM AK CCK TIB INSER SZ2-16MM AK CCK TIB INSER SZ2-22MM AK CCK TIB INSER SZ2-30MM AK CCK TIB INSER SZ3-16MM AK CCK TIB INSER SZ3-22MM AK CCK TIB INSER SZ3-25MM AK CCK TIB INSER SZ4-13MM AK CCK TIB INSER SZ4-16MM AK CCK TIB INSER SZ5-11MM AK CCK TIB INSER
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-1261-2014. 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.