Z-0586-2014 Class II Terminated
FDA device recall Z-0586-2014 was initiated by Zimmer, Inc. on Nov 5, 2013 and is designated Class II. 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… The recall status is terminated (terminated May 5, 2015). Affected quantity: 42, 065 units total.
Recall Details
- Product Type
- Devices
- Report Date
- Jan 8, 2014
- Initiation Date
- Nov 5, 2013
- Termination Date
- May 5, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 42, 065 units total
Product Description
TIBIO FEM/FEM NAIL.
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
Distribution Pattern
Worldwide Distribution.
Code Information
Item Numbers 32-8553-311-11 32-8553-311-13 32-8553-311-15 32-8553-311-17 All lots with an expiration date prior to July 24, 2023
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0586-2014
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026