Apex Knee System components recalled over loss of sterile packaging integrity

Plain-English summary

The Apex Knee System is being recalled across the model numbers listed in the recall notice, including KC-50090, KC-50110, KC-50130, KC-50157, KC-52104 and KC-55223. The action covers 341 units, identified by the serial numbers paired with each model number in the notice.

The stated reason is that an investigation has identified that the age of the nylon packaging material has caused a loss of integrity of some pouches. The FDA classified the action as Class II.

Distribution was nationwide in the United States, in California, Colorado, Florida, Illinois, Oklahoma, Texas and Utah. The components are supplied to surgical facilities rather than sold to consumers.

Facilities should identify affected stock using the model and serial numbers in the recall notice, quarantine it, and follow the instructions issued by the manufacturer.

The recalled product

Product

Apex Knee System. Model Numbers: KC-50090, KC-50097, KC-50110, KC-50117, KC-50130, KC-50135, KC-50137, KC-50150, KC-50155, KC-50157, KC-50170, KC-50175, KC-50177, KC-50190, KC-50197, KC-52104, KC-52554, KC-52574, KC-52774, KC-55223, KC-55243

Manufacturer

CORIN MEDICAL, LTD.

Category

Medical Device — Orthopaedic implant

Hazard

• sterile-barrier
• packaging-integrity
• implant
• class-ii

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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