NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component… — Class II medical device recall Z-0437-2013
Terminated recall by Zimmer, Inc., reported 2012-12-05, distributed in AZ, CA, FL, IA, IL, IN, MO, NE…. Zimmer is initiating a lot specific recall of the NexGen¿ Stemmed Nonaugmentable Tibial Component due to the d
| Recall number | Z-0437-2013 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2012-09-21 |
| Classified | 2012-11-26 |
| Reported by FDA | 2012-12-05 |
| Terminated | 2014-04-17 |
| Distributed | AZ, CA, FL, IA, IL, IN, MO, NE, NJ, NY, OH, PA, WA |
| Countries outside the US | CA, DE, FR, GB, HU, NL, SE, TH |
| Reason classes | foreign material, specification failure |
| Lot numbers | 62045235, 62049114 |
| Model numbers | 00-5986-047-02, 62045235, 62049114 |
Product
NexGen CompleteKnee Solution Stemmed Nonaugmentable Tibial component The NexGen¿¿ system is a semiconstrained, nonlinked condylar knee prostheses. The device is indicated for patients with severe knee pain and disability due to rheumatoid arthritis; osteoarthritis; traumatic arthritis; polyarthritis; collagen disorders and/or avascular necrosis of the femoral condyle; post-traumatic loss of joint configuration (particularly when there is patellofemoral erosion, dysfunction or prior patellectomy); moderate valgus, varus or flexion deformities; salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
Reason for recall
Zimmer is initiating a lot specific recall of the NexGen¿ Stemmed Nonaugmentable Tibial Component due to the devices being processed through a manufacturing cleaning operation that was operating outside of the validated parameters. As a result, the devices may contain residual particulate from the manufacturing process. Risks include: Allergic reaction due to the foreign material or late onset
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-0437-2013. 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.