Apex Knee System Tibial Baseplate Recalled for Packaging Date Error
OMNIlife science Inc. is recalling 32 Apex Knee System Tibial Baseplates due to an incorrect expiration date on the external packaging.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a documentation and packaging error where the correct date is present in internal packaging and sterile batch documentation, fitting the 'packaging-only problems' criterion for a Low severity score.
Plain-English summary
OMNIlife science Inc. is recalling 32 units of the Apex Knee System, Tibial Baseplate Size 6 Left, non-porous (Product Code KC-2206L, Lot # 26519). The recall is due to an improper expiration date (2202-03) marked on the external packaging. The correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.
The affected devices were distributed worldwide, including in the United States and Spain. The Apex Knee System is intended for use as a primary or revision total knee replacement with cemented fixation and single use implantation.
Healthcare providers and facilities should stop using the affected devices and contact the manufacturer for instructions on return or disposal.
The recalled product
- Product
- Apex Knee System, Tibial Baseplate Size 6 Left, non-porous - KC-2206L The Apex Knee System is intended for use as a primary or revision total knee replacement. This knee replacement system is intended for cemented fixation and single use implantation. This prosthesis may be us
- Manufacturer
- OMNIlife science Inc.
- Hazard
- Affected units
- 32
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 (2)
- Product Code KC-2206L
- Lot # 26519
Distribution
Distribution scope not specified by the agency.
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