FDA-Device2020-03-04Class II
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
Zimmer Biomet, Inc.
Hazard
Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
Sold states
Domestic distribution to AL CA FL IA IL MD MI MN MO MS NC NE NJ NY PA TX UT VA WA WI
Affected count
1662
Manufactured in
56 E Bell Dr, N/A, Warsaw, IN, United States
Products
THP Hip Plating System, Item Nos. 14-451070 14-451075 14-451080 14-451085 14-451090 14-451095 14-451100 14-451105 14-451110 14-451115 14-451120 14-451125 14-451130 . The product is a metallic bone fixation system.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1347-2020Don't want to check this manually?
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