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Recall Observatory FDA recall evidence

Device product

ZCA All Poly Acetabular Cup Longevity Crosslinked Polyethylene, I.D. 22 mm, Neutral, O.D. Cup with Spacers, 53 mm Item Number: 00-8065-550-22

Z-0337-2021

September 24, 2020

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 86521
Status
Terminated
Classification
Class II
Quantity
412 units total
Official record key
device-enforcement:Z-0337-2021

Official wording

Reason: Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.

Code information: All lots

Distribution pattern: US Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Sterilant (hydrogen peroxide) used in acetabular cup hip prosthesis component was not evaluated to confirm the biocompatibility of the residual sterilant. Cannot rule out the potential for adverse tissue reactions.