Recall Z-1347-2020 ยท JDO Device, Fixation, Proximal Femoral, Implant
Zimmer Biomet, Inc.
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.
| Date | Jan 29, 2020 (initiated Jan 7, 2020) |
| Status | Terminated |
| Reason | Potential increase in fracture rate was detected during internal testing, in addition to potential discoloration inside the inner pouch of the packaging. |
| Root cause | Under Investigation by firm |
| Action | On January 7, 2020, the firm distributed Urgent Medical Device Recall letters to affected customers. Customers were instructed to take the following actions: 1. Review the recall information and ensure that affected personnel are aware of the contents. 2. If you have affected product at your facility, assist your Zimmer Biomet sales representative and quarantine all affected product. The sales representative will remove the affected product from your facility. 3. There are no specific patient monitoring instructions related to this recall that are recommended beyond the existing follow-up s |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K140018 | TSP HIP FRACTURE PLATING SYSTEM Biomet, Inc., Apr 4, 2014 |