Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral… — Class II medical device recall Z-2092-2012
Terminated recall by Zimmer Inc., reported 2012-08-08, distributed nationwide. The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring cl
| Recall number | Z-2092-2012 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer Inc., Warsaw, IN, United States |
| Recall initiated | 2012-04-30 |
| Classified | 2012-07-27 |
| Reported by FDA | 2012-08-08 |
| Terminated | 2014-06-04 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, DE, FI, HK, IN, JP, SG |
| Quantity | 65 units |
| Reason classes | device malfunction |
| Lot numbers | 61813699, 61870067, 62011774 |
| Model numbers | 00-5901-026-40 |
Product
Nextgen Complete Knee Solution Replacement Jaw for Use with Femoral and Provisional Impactor/Extractor, REF 00-5901-026-40, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Reason for recall
The design of the spring clip for the jaw assembly was updated in March 2011 due to fractures of the spring clip. Zimmer has received complaints for the spring clip fracturing on the updated design. The spring clip may fracture or fall off of the instrument during use, and a device fragment may be left in the surgical site. The risk of disassembly or fracture occurs when the instrument is typicall
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-2092-2012. 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.