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Recall Observatory FDA recall evidence

Device product

M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093

Z-1046-2016

February 11, 2016

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 73298
Status
Terminated
Classification
Class II
Quantity
9 units
Official record key
device-enforcement:Z-1046-2016

Official wording

Reason: Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.

Code information: Item: 00-7711-012-20, Lot: 62937093

Distribution pattern: Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Zimmer Biomet initiated a lot-specific voluntary recall on 02/11/2016, of the M/L Taper Hip Prosthesis. single manufacturing lot of Size 12.5, Extended Offset, M/L Taper hip stems was incorrectly etched. The device was etched as STD, rather than EXT. The product packaging is labeled correctly as Extended. Offset, and the device is an extended offset stem.