Apex Knee System components recalled over loss of sterile packaging integrity
Apex Knee System components are being recalled because the age of the nylon packaging material has caused a loss of integrity of some pouches. 341 units are affected.
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: Risk-of-harm product: a compromised sterile barrier on an implantable orthopaedic component, with no injury reported in the source.
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.
- Affected units
- 341
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 (20)
- Model Number (Serial Numbers): KC-50090(580854
- 582278)
- KC-50097(528456
- 528457)
- KC-50110(531527
- 532301
- 586311)
- KC-50117(552924)
- KC-50130(528458
- 548885
- 548886
- 548887
- 548888
- 573259)
- KC-50135(529093)
- KC-50137(527387
- 528459
- 555044
- 568751)
- KC-50150(529072
Distribution
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