Recall Z-1347-2020— Zimmer Biomet, Inc.
Class II · Terminated
Class II FDA medical device recall by Zimmer Biomet, Inc., initiated 2020-01-07, terminated 2021-04-08. It names one FDA 510(k) clearance: K140018. 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: Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging..
- Recalling firm
- Zimmer Biomet, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-07
- Terminated
- 2021-04-08
- Firm location
- Warsaw, IN, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.