FDA Device recall Z-2091-2012
Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The inst…
- FDA Device
- Class II
- terminated
- Published 2012-08-08
On 2012-08-08 the FDA classified a Class II recall of Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The inst… by Zimmer, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2091-2012 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-04-30 |
| Published | 2012-08-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Zimmer |
| Distribution | US |
Product
Nextgen Complete Knee Solution Femoral and Provisional Impactor/ Extractor, REF 00-5901-026-00, Non-Sterile Zimmer, Warsaw Indiana The instrument is attached to the femoral implant or provisional to aid in positioning and inserting the components.
Reason
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
Identifiers
| code_info | Part 00-5901-026-00 Lot 11002148, 11002149, 11002791, 11002792, 11002831, 11003439, 11003449, 61800676, 61814993, 6190…Part 00-5901-026-00 Lot 11002148, 11002149, 11002791, 11002792, 11002831, 11003439, 11003449, 61800676, 61814993, 61909414, 61924920, 61980656, 61985378, 61988272, 61990656, 62003795, 62011220, 77000065, 77000573, 77000574, 77000575, 77000583, 77000654, 77000786, 77000787, 77000788, 77000789, 77000790, 77000795, 77000797, 77000798, 77000799, 77000804, 77000848, 77000849, 77000872, 77000873, 77001039, 77001048, 77001096, 77001097, 77001118, and 77001119 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2091-2012%22
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