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Recall Observatory FDA recall evidence

Device product

M/L Taper Hip Prosthesis Extended Offset, Reduced Neck Length, Size 4 (Item Number 00771100640) and Size 6 (Item Number 00771100440)

Z-2519-2023

July 26, 2023

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 92889
Status
Ongoing
Classification
Class II
Quantity
24 units
Official record key
device-enforcement:Z-2519-2023

Official wording

Reason: The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.

Code information: Item Number: 00771100640, UDI-DI: 00889024131699, Lot Number: 65236202; Item Number: 00771100440, UDI-DI: 00889024131613, Lot Number: 65249215

Distribution pattern: Worldwide - US Nationwide distribution in the states of AL, CA, GA, MI, NJ, PA, TN, and WI. The countries of Brazil, Canada, Netherlands.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The outer package labeling and product etch are for a Size 6, however, the implant is a Size 4, and vice versa.