NexGen Complete Knee Solution — Class II medical device recall Z-1938-2014
Terminated recall by Zimmer, Inc., reported 2014-07-09, distributed nationwide. Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may
| Recall number | Z-1938-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-05-19 |
| Classified | 2014-06-27 |
| Reported by FDA | 2014-07-09 |
| Terminated | 2015-10-29 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CN, HK, IN, JP, KR, MY, NI, SG, TW |
| Quantity | 41,180 total |
| Reason classes | specification failure |
| Lot numbers | 370320, 37214653, 61424998, 61442326, 61459971, 61459972, 61488229, 61518205, 61543979, 61658887, 61658888, 61827120, 61827121, 61827122, 61979040, 61979041, 62051526, 62091729, 62200288, 62227423, 62251572, 62330688, 62383359, 62383362, 62401016, 62401017, 62602812, 62602813, 62640983 |
Product
NexGen Complete Knee Solution, MIS Total Knee Procedure, Stemmed Tibial Component, Precoat, Fixed Bearing, Size 7. Part of the NexGen systems of semi-constrained, non-linked condylar knee prosthesis.
Reason for recall
Zimmer is initiating a voluntary recall of specific identified lots due to the potential that the threads may be out of specification.
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-1938-2014. 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.