Z-1117-2018 Class II Terminated
FDA device recall Z-1117-2018 was initiated by OMNIlife science Inc. on November 20, 2017 and is designated Class II. Reason for recall: The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The… The recall status is terminated (terminated June 7, 2019). Affected quantity: 32.
Recall Details
- Product Type
- Devices
- Report Date
- March 28, 2018
- Initiation Date
- November 20, 2017
- Termination Date
- June 7, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 32
Product Description
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 used for the following conditions, as appropriate: Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis; Rheumatoid arthritis; Correction of functional deformity; Revision procedures where other treatments or devices have failed.
Reason for Recall
The Apex Knee System Tibial Baseplate identified has an improper expiration date marked on the external packaging. The improper expiration date (2202-03) is marked on the external packaging only. The correct lot number (2022-03) is present in the internal packaging and sterile batch documentation.
Distribution Pattern
Worldwide Distribution - US Distribution and to the country Spain.
Code Information
Product Code KC-2206L, Lot # 26519