FDA recall Z-1347-2020

Product

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.

Distribution

Domestic distribution to AL CA FL IA IL MD MI MN MO MS NC NE NJ NY PA TX UT VA WA WI

Key facts

Status

Terminated

Initiation date

2020-01-07

Report date

2020-03-04

Termination date

2021-04-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1347-2020