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.
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 1/5 (Low).
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…
- 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.
Related recalls
Same manufacturer · OMNIlife science Inc.
See all →- SevereOMNIlife Recalls SERF Novae Dual Mobility Cup Inserts Due to Oxidation
FDA (Devices) · 2021-02-03
- HighOmnIlife Science Recalls Hip Replacement Liners Due to Oxidation Limits
FDA (Devices) · 2021-02-03
- SevereOMNIlife Science Recalls SERF Novae Dual Mobility Cup Inserts
FDA (Devices) · 2021-02-03
- HighOMNI Hip System Femoral Component Recalled for Missing Porous Coating
FDA (Devices) · 2019-10-30
- SevereOMNIlife ApeX Acetabular Liner Recalled for Oxidation Test Failure
FDA (Devices) · 2019-09-11
Same hazard · mis labeling
See all →- SevereImperio Distribution Recalls Beef Jerky Produced Without Federal Inspection
USDA FSIS · 2026-10-24
- HighJ K Patisserie Chocolate Chip Cookies Recalled for Undeclared Soy
FDA (Food) · 2026-10-14
- HighFreshPoint Recalls Cranberry Chicken Salad Wedges for Undeclared Egg Allergen
FDA (Food) · 2026-10-14
- HighJ K Patisserie & Bakery LLC Recalls Croissants for Undeclared Egg
FDA (Food) · 2026-10-14
- LowMindray ePM Series Patient Monitor Manuals Recalled for Alarm Clarification
FDA (Devices) · 2026-10-14
Similar recalls
- HighOmni Life Science Recalls Apex Knee System Modular Tibia Augments
FDA (Devices) · 2012-09-19
- HighOmnilife Apex Knee System Modular Tibia Augment Recalled for Sterility Breach
FDA (Devices) · 2012-09-19
- HighOmni Life Science Apex Knee System Modular Tibia Augment Recall
FDA (Devices) · 2012-09-19
- HighOmni Life Science Apex Knee System Modular Tibia Augment Recalled for Sterility Breach
FDA (Devices) · 2012-09-19
- HighOmni Life Science Recalls Apex Knee System Tibia Augments
FDA (Devices) · 2012-09-19
- ModerateOMNI Hip System Acetabular Inserts Recalled for Improper Labeling
FDA (Devices) · 2018-08-01