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Recall Observatory FDA recall evidence

Device product

NCB PERIPROSTHETIC, "NCB PP PROX FEM PLATE", Various sizes, Item Nos. 0202263009 0202263012 0202263015 0202263018 0202263021 0202263109 0202263112 0202263115 0202263118 0202263121 0202264009 0202264012 0202264015 0202264018 0202264021 0202264109 0202264112 0202264115 0202264118 0202264121 0202265010 0202265012 0202265014

Z-0304-2020

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-0304-2020

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).