FDA recall Z-1117-2018

OMNIlife science Inc. · Class II · device

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 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

Worldwide Distribution - US Distribution and to the country Spain.

Key facts

Status
Terminated
Initiation date
2017-11-20
Report date
2018-03-28
Termination date
2019-06-07
Voluntary/Mandated
Voluntary: Firm initiated
Location
Raynham, MA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1117-2018