The Recall Desk
HighFDA (Devices)·Z-1934-2024·Announced 2024-06-12

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.

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 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
Category
Medical Device — Orthopedic Implant
Hazard
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

Distributed nationwide across the United States.

The notice also names 6 states specifically:

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

Same manufacturer · CORENTEC CO., LTD

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Same hazard · material degradation

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