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Recall Observatory FDA recall evidence

Device product

cable button for NCB¿ Polyaxial Locking Plate, 2.5 mm Hex Drive, Item No. 47223206001

Z-0338-2020

October 10, 2019

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 83962
Status
Terminated
Classification
Class II
Quantity
5459583 total devices
Official record key
device-enforcement:Z-0338-2020

Official wording

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

Code information: 12752657 12784266 12784266 12784266 12778187 12778187 12752661 12784267 12784267 12784267 12776194 12784268 12784268 12784268 12774326 12753709 12753702 12753707 12784261

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).