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Recall Observatory FDA recall evidence

Device product

Prox Lat Tib Lock Plate and Dist Med Tib Lock Plate Item Nos. 47235700306 47235700308 47235700310 47235700312 47235700314 47235700408 47235700410 47235700412 47235700414 47235700416 47235700504 47235700506 47235700508 47235700510 47235700512 47235700514 47235700518 47235700604 47235700606 47235700608 47235700610 47235700612 47235700614 47235700618 47235700706 47235700708 47235700710 47235700714 47235700808 47235700810 47235700814 47235700906 47235700908 47235700914 47235700918 47235701006 47235701008 47235701010

Z-0309-2020

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-0309-2020

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).