Stryker Recalls 80 mm Kinemax Stem Extenders Due to Mislabeling
Stryker Howmedica Osteonics is recalling four 80 mm Kinemax Stem Extenders because they were shipped in boxes labeled for the 80 mm part but contained 40 mm extenders.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error where the wrong size component was shipped. While this is a significant quality control issue for a medical device, the source text does not report any injuries, illnesses, or deaths, fitting the criteria for a moderate severity recall involving labeling errors.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling four units of Kinemax Stem Extenders, 80 mm (Catalog No. 6476-8-260, Lot code: EJPLC). The recall was initiated after the company received four customer complaints indicating that the boxes were labeled for the 80 mm part number but actually contained the 40 mm part number (6476-8-250).
These modular components are designed to be mated with tibial baseplates or femoral components of specific knee replacement systems, including the Modular Rotating Hinge (MRH), Scorpio Total Stabilizer (TS), or Duracon TS. The 80 mm extenders are indicated for use in all three of these systems. The distribution was limited to the United States, specifically in the states of Massachusetts and Rhode Island.
Healthcare providers and patients should verify the part number of any installed or stored Kinemax Stem Extenders against the box label. If a discrepancy is found where an 80 mm box contains a 40 mm extender, the product should be removed from use and the manufacturer contacted for instructions.
The recalled product
- 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
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 4
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Catalog No. 6476-8-260
- Lot code: EJPLC
Distribution
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