Device product
TIBIO FEM/FEM NAIL.
Z-0586-2014
Product summary
- Firm
- Zimmer, Inc.
- Event
- Event 66499
- Status
- Terminated
- Classification
- Class II
- Quantity
- 42, 065 units total
- Official record key
device-enforcement:Z-0586-2014
Official wording
Reason: 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
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
Distribution pattern: Worldwide Distribution.
Derived failure modes
-
Unknown
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