Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT… — Class II medical device recall Z-1262-2014
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-1262-2014 |
|---|---|
| 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 | 621800809, 621801809, 621801819, 621801913, 621801916, 621810816, 621810909, 621820809, 621820811, 621820911, 621830811, 621830909, 621850916 |
Product
Natural-Knee¿ II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA TIB RT SZ0/16M ALL POLY ULTRA TIB LT SZ1 ALL POLY ULTRA TIB RT SZ1 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB RT SZ2 ALL POLY ULTRA TIB LT SZ3 ALL POLY ULTRA TIB RT SZ3 ALL POLY ULTRA TIB RT SZ5
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-1262-2014. 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.