# FDA recall Z-1117-2018

> **OMNIlife science Inc.** · Class II · device recall initiated 2017-11-20.

## 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

- **Recall number:** Z-1117-2018
- **Recalling firm:** OMNIlife science Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1117-2018. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/Z-1117-2018. Source: US FDA. Licensed CC0.

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