Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology — Class II medical device recall Z-2035-2014
Terminated recall by Zimmer, Inc., reported 2014-07-16, distributed nationwide. Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
| Recall number | Z-2035-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Zimmer, Inc., Warsaw, IN, United States |
| Recall initiated | 2014-05-23 |
| Classified | 2014-07-10 |
| Reported by FDA | 2014-07-16 |
| Terminated | 2015-03-06 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CN, IN, JP, KR, SG |
| Quantity | 315 units |
| Reason classes | sterility |
| Lot numbers | 11001594, 11001595, 11001596, 11002955, 11003622, 60617023, 60617024, 60803338, 60815998, 60819830, 60837142, 60841248R, 60845838, 60898841, 60940196, 60940201, 60958672, 61040881, 61081253, 61300903, 61326522, 61356738, 61409710, 61468347, 61542773, 61548886, 61576325, 61576337, 61613909, 61613958, 61694618, 61719863, 61729730, 61735132, 61741697, 61743290, 61743314, 61768416, 61781830, 61786474 and 239 more |
Product
Zimmer M/L Taper Hip Prosthesis with Kinectiv Technology, HIP JOINT PROSTHESIS¿, Sizes:4, 5, 6, 7.5, 9, 10, 11 & 12.5. The femoral stem component of a modular system that consists of an acetabular component, femoral head, femoral stem, and the instrumentation necessary for proper implantation of these components.
Reason for recall
Black residue observed in the sterile pouch of the M/L Taper and Kinectiv stems.
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-2035-2014. 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.