Stryker Tibial Offset Bushing Recall Due to Incorrect Markings
Stryker Howmedica Osteonics is recalling 8 Tibial Offset Bushings because rotational reference numbers were marked incorrectly or missing.
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/marking error on a surgical instrument. No injuries or illnesses are reported in the source text, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling eight units of Tibial Offset Bushings (Catalog Number 6543-2-600) associated with the Triathlon TS system. The affected lots are P1S43 and P2A31. These instruments are used during surgical trialing to assess the appropriate magnitude and orientation of offset between the implant and the intramedullary stem.
The recall was initiated because the offset bushings were mismarked. Specifically, the rotational reference numbers on the Tibial Offset Bushing were marked counterclockwise instead of clockwise, and the Femoral Offset Bushing did not include rotational markings. The products were distributed worldwide.
Healthcare providers and consumers should stop using the affected instruments and contact Stryker Howmedica Osteonics Corp. for further instructions. The recall is classified as Class II by the FDA.
The recalled product
- Product
- Stryker Orthopaedics TIBIAL OFFSET BUSHING TRIATHLON REVISION INSTRUMENTS REF 6543-2-600;NON-STERILE Howmedica Osteonics Corp. 325 Corporate Drive Mahwah, NJ 07430 USA A Subsidiary of Stryker Corp. Stryker France ZAC Satolas Green Pusignan Av de Satolas Green 69
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 8
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 (3)
- Class I
- 510(k) exempt Catalog Number: 6543-2-600 Lot Number: P1S43
- P2A31
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Stryker Howmedica Osteonics Corp. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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