Recall record at a glance
| Official record | Z-1614-2015 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Stryker Howmedica Osteonics Corp. |
| Report date | May 20, 2015 |
| Recall initiation date | Feb 27, 2015 |
| Quantity | 4 units |
| Location | Mahwah, NJ, United States |
Official product description
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.
Why the product was recalled
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.
Distribution information
US Nationwide distribution in the states of MA and RI.
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: E-Mail.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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