Recall Z-0853-2022 · JDR Staple, Fixation, Bone
Wright Medical Technology, Inc.
EasyFuse Dynamic Compression System Instrument Pack
| Date | Mar 10, 2022 |
| Status | Terminated |
| Reason | The drill and adjustable drill guide can jam/bind intraoperatively resulting in the drill guide breaking. |
| Root cause | Device Design |
| Action | A recall notice was disseminated to the distributor and sales representatives via email (09-Mar-2022 and 10-Mar-2022) and to the hospitals via mail (10-Mar-2022, FedEx Priority Overnight). The hospital letters were delivered on 11-Mar-2022. Customers were instructed to immediately check all stock areas and/or operating room storage to determine if any devices from the affected product list are at your facility and remove them from their point of use. They are to return the enclosed business reply form by email to confirm receipt of the notification/document product segregation. Upon receipt of |
| Quantity | 176 packs |
| Distribution | US distribution to Florida, North Carolina, Ohio, and Texas |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K203832 | FuseForce Flex Dynamic Compression System Wright Medical, May 7, 2021 |