FDAFDA · Food and drugs·Recall number Z-0587-2014
DIST LAT FEM LOCK PLT, LT
Published January 8, 2014 · Recall initiated: November 5, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Zimmer, Inc.
- Distributor
- Worldwide Distribution.
- Lot
- Item Number: 47-2357-102-14 47-2357-102-18 All lots with an expiration date prior to July 24, 2023
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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