LOSPA Tibial Insert Knee Implant Component Recalled for Unsupported Expiration Date
CORENTEC is recalling LOSPA Tibial Insert knee implant components due to an unsupported 10-year expiration date. Patients with these devices should consult their physician.
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: FDA Class II recall concerning an unsupported expiration date on orthopedic knee implant components. While no illnesses or injuries have been reported, joint implants are high-risk products where material degradation beyond their supported lifespan could result in implant failure requiring revision surgery.
Plain-English summary
CORENTEC CO., LTD is recalling 397 LOSPA Tibial Insert knee implant components nationwide due to an unsupported 10-year expiration date. The recalled devices include LOSPA Tibial Insert (CR) and (PS) models, as well as LOSPA Fixed Constrained Tibial Insert models, distributed across Alabama, Arizona, California, Michigan, Pennsylvania, and Texas.
The manufacturer's expiration date labeling for these devices is not supported by the company's validation data. Using implant components beyond their supported expiration period may result in unpredictable device performance or material degradation.
Patients who have received these implants should contact their healthcare provider or surgeon to determine if their specific device is affected and whether any medical evaluation or device replacement is necessary. Patients experiencing pain, instability, or other joint-related symptoms should seek immediate medical attention.
The recalled product
- Product
- LOSPA Tibial Insert Model/Catalog Number: See below Software Version: N/A Product Description: Tibial Insert
- Manufacturer
- CORENTEC CO., LTD
- Affected units
- 397
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 (6)
- K2.IBN.4264-XXX
- K2.IBN.4467-XXX
- K2.IBN.4672-XXX
- K2.IBN.4874-XXX
- K2.IBN.5076-XXX
- K2.IBN.5281-XXX
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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