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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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
- Affected units
- 35
Distribution
Part of a larger recall action
This product is one of 2 recalled by CORENTEC CO., LTD 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.
See all 2 products in this recall →Related recalls
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