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Recall Observatory FDA recall evidence

Device product

FEM COND BUTTRESS PLT, LT

Z-0591-2014

November 05, 2013

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 66499
Status
Terminated
Classification
Class II
Quantity
42, 065 units total
Official record key
device-enforcement:Z-0591-2014

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 #'s: 00-2347-002-12 00-2347-002-14 00-2347-002-16 00-2347-002-18 Lot #s: All lots with an expiration date prior to July 24, 2023

Distribution pattern: Worldwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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