DIST LAT FEM LOCK PLT, RT
Reported: January 8, 2014 Initiated: November 5, 2013 #Z-0588-2014
Product Description
DIST LAT FEM LOCK PLT, RT
Reason for Recall
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
Details
- Recalling Firm
- Zimmer, Inc.
- Units Affected
- 42, 065 units total
- Distribution
- Worldwide Distribution.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
DIST LAT FEM LOCK PLT, RT. Recalled by Zimmer, Inc.. Units affected: 42, 065 units total.
Why was this product recalled? ▼
Based on a review of historic packaging validations, it was determined that a subset of product packaged at a Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. This testing determined that a packaging tray configuration which consists of an inner and outer sterile tray, resulted in failure
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 8, 2014. Severity: Moderate. Recall number: Z-0588-2014.
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