Kinemax Stem Extenders — Class II medical device recall Z-1614-2015
Terminated recall by Stryker Howmedica Osteonics Corp., reported 2015-05-20, distributed nationwide. Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem
| Recall number | Z-1614-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Howmedica Osteonics Corp., Mahwah, NJ, United States |
| Recall initiated | 2015-02-27 |
| Classified | 2015-05-14 |
| Reported by FDA | 2015-05-20 |
| Terminated | 2016-10-13 |
| Distributed | Nationwide (US) |
| Quantity | 4 units |
| Reason classes | labeling |
| Model numbers | 6476-8-250, 6476-8-260, 6476-8-270 |
Product
Kinemax Stem Extenders, 80 mm, Product Usage: Kinemax Cemented Stem Extenders are modular components designed to be mated with tibial baseplates or femoral components of the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS) or Duracon TS knee replacement systems. The Kinemax Cemented Stem Extenders are available in three different lengths, 40 mm (Part #6476-8-250), 80mm (Part #6476-8-260) and 155mm (Part #6476-8-270). The 40 mm cemented stem extender is not indicated for use in the MRH system; however, it is indicated for use with the Scorpio TS and Duracon TS systems (LRKS/G Rev. 2). Both the 80mm and 155mm stem extenders are indicated for use in all three systems.
Reason for recall
Stryker received four customer complaints reporting that inside the box labeled part #6476-8-260 (Kinemax Stem Extenders, 80 mm) there was a different part #6476-8-250 (Kinemax Stem Extenders, 40 mm.
Machine access
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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.