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Recall Observatory FDA recall evidence

Device product

Maximum Variable Pitch Compression Tray Base, Reference Number 231201002 Product Usage: Intended to carry implants and instruments during regular inventory distribution and handling and sterilization in the hospitals

Z-0734-2019

November 28, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 81758
Status
Terminated
Classification
Class II
Quantity
971 i nTotal
Official record key
device-enforcement:Z-0734-2019

Official wording

Reason: There is a potential for silicone shedding during cleaning and sterilization.

Code information: Lot Numbers 453392 453918 453919 469917 475577 481064 481065 486820 498695 506818 512868

Distribution pattern: Worldwide Distribution - US Nationwide, The products were distributed to the following foreign countries: Australia, Chile, Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    There is a potential for silicone shedding during cleaning and sterilization.