LOSPA Patella Knee Component Recalled for Unsupported Expiration Date
CORENTEC's LOSPA Patella Component knee implants are recalled due to an unsupported 10-year expiration date. Thirty-five units were distributed nationwide.
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: This is an FDA Class II recall of an orthopedic implant component with an unsupported expiration date, creating a risk of implant failure and patient harm. Although no adverse events have been reported, the product qualifies as a risk-of-harm device per the rubric criterion for Score 3.
Plain-English summary
CORENTEC CO., LTD is recalling LOSPA Patella Component knee replacement implants in multiple sizes (26mm, 30mm, 32mm, 34mm, 38mm, and 40mm) due to an unsupported 10-year expiration date. The company has not validated that these components remain safe and effective beyond 10 years of use.
Thirty-five units were distributed nationwide to hospitals and surgical centers in Alabama, Arizona, California, Michigan, Pennsylvania, and Texas. Affected product models include the LOSPA Knee System models 01.10.921, 01.10.961, 01.10.981, 01.10.9A2, 01.10.9EC, and 01.10.9GC.
Patients who have received this implant should contact their healthcare provider to discuss their individual implant status and any concerns. Healthcare facilities should review their inventory and patient records for any affected components. For specific lot numbers and expiration dates, refer to the FDA recall notice.
The recalled product
- Product
- LOSPA Patella Component Model/Catalog Number: 01.10.9XX Software Version: N/A Product Description: Patella
- Manufacturer
- CORENTEC CO., LTD
- Hazard
- unsupported-expiration-date
- implant-failure-risk
Distribution
Distributed nationwide across the United States.
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