FDA-Device2016-03-16Class II
M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
Zimmer Biomet, Inc.
Hazard
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.
Sold states
Distributed in the states of SD, MO, NY, MI, PA, KY and TN and in the country of Argentina.
Affected count
9 units
Manufactured in
1800 W Center St, N/A, Warsaw, IN, United States
Products
M/L Taper Hip Prosthesis (Item: 00-7711-012-20, Lot: 62937093
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1046-2016Don't want to check this manually?
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