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Recall Observatory FDA recall evidence

Device product

ZPLP Fibular Plate, Item Nos. 00234701504 00234701506 00234701508 00234701510 00234701512 00234701516 00234701604 00234701606 00234701608 00234701610 00234701612 00234701614 00234701616 00234701702 00234701704 00234701706 00234701708 00234701710 00234701712 00234701714 00234701716 00234701718 00234701802 00234701804 00234701806 00234701808 00234701810 00234701812 00234701814 00234701816 00234701818 47235701704 47235701706 47235701708 47235701710 47235701712 47235701714 47235701716 47235701804 47235701806 47235701808 47235701810 47235701812 47235701814 47235701816

Z-0305-2020

October 10, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83962
Status
Terminated
Classification
Class II
Quantity
5,459,583 total devices
Official record key
device-enforcement:Z-0305-2020

Official wording

Reason: Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).

Code information: All product manufactured prior to January 2014.

Distribution pattern: Distributed nationwide.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).