PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: March 4, 2020 Initiated: January 7, 2020 #Z-1347-2020

Product Description

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.

Reason for Recall

Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.

Details

Recalling Firm
Zimmer Biomet, Inc.
Units Affected
1662
Distribution
Domestic distribution to AL CA FL IA IL MD MI MN MO MS NC NE NJ NY PA TX UT VA WA WI
Location
Warsaw, IN

Frequently Asked Questions

What product was recalled?
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.. Recalled by Zimmer Biomet, Inc.. Units affected: 1662.
Why was this product recalled?
Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging.
Which agency issued this recall?
This recall was issued by the FDA Devices on March 4, 2020. Severity: Moderate. Recall number: Z-1347-2020.