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Recall Observatory FDA recall evidence

Device product

LPS-MOB ART SURF IMPL D 9MM

Z-0324-2020

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-0324-2020

Official wording

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

Code information: 62067796

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).