Stryker Orthopaedics Recalls Mismarked Femoral Offset Bushing Instruments
Stryker Howmedica Osteonics Corp. is recalling 7 units of non-sterile Femoral Offset Bushing Triathlon Revision Instruments due to incorrect or missing rotational markings.
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 (mismarked rotational references) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Stryker Howmedica Osteonics Corp. is recalling 7 units of the Stryker Orthopaedics Femoral Offset Bushing Triathlon Revision Instruments, catalog number 6543-1-600, lot number NE1WR1. These non-sterile instruments are parts of the Triathlon TS system 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 associated with the identified lot 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 facilities that have received these instruments should stop using them 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 FEMORAL OFFSET BUSHING TRITHION REVISION INSTRUMENTS REF 6543-1-600;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 69881
- Manufacturer
- Stryker Howmedica Osteonics Corp.
- Hazard
- Affected units
- 7
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: 6543-1-600 Lot Number
- NE1WR1
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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