Stryker INBONE Tibial Tray recalled for oversized lock detail defect
Wright Medical Technology is recalling one Stryker INBONE Tibial Tray due to an oversized tibial tray lock detail that exceeds product specifications and could affect device functionality.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a manufacturing defect in an orthopedic implant that presents a risk of device malfunction or failure. No injuries or adverse events have been reported, consistent with the rubric criterion for High severity (risk-of-harm products without reported injury).
Plain-English summary
Wright Medical Technology, Inc. is recalling a single Stryker INBONE Tibial Tray (REF 200252904, Size 4, Lot Code 1725563) that was distributed in New York. The tibial tray lock detail is oversized, exceeding the product's specifications.
This manufacturing defect could compromise the proper fit and function of the knee implant. The oversized lock detail may prevent proper seating or locking of the component, potentially leading to implant failure or unexpected performance issues.
Patients who received this specific implant should contact their healthcare provider or surgeon immediately. Healthcare providers should review patient records to identify anyone who may have received this recalled unit and assess whether clinical intervention is necessary.
No injuries or adverse events associated with this defect have been reported to the FDA as of this notice.
The recalled product
- Product
- Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
- Manufacturer
- Wright Medical Technology, Inc.
- Hazard
- manufacturing-defect
- implant-malfunction
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)
- GTIN 00840420124159
- Lot Code: 1725563
Distribution
Distributed nationwide across the United States.
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