Recall Z-2965-2018 ยท HRS Plate, Fixation, Bone
Zimmer Biomet, Inc.
Peg Fully Threaded, Locking, 2.5mm x 10mm, Item Number 131212610 Orthopedic device used for stabilization and fixation of small bone fragments Intended for stabilization and fixation of small bone fragments in fresh fractures, revision procedures, joint fusion and reconstructions of small bones of the hand, foot, wrist, ankle, humerus, scapula, finger, toe, pelvis and craniomaxillofacial skeleto
| Date | Jul 12, 2018 |
| Status | Terminated |
| Reason | A size 22mm threaded peg was found in the package of a 10mm unit. |
| Root cause | Under Investigation by firm |
| Action | The firm, Zimmer Biomet, sent an "Urgent Medical Device Recall " letter dated 7/12/18, to customers. The described the product, problem and actions to be taken.The letter instructed Risk Managers to perform the following actions: 1. Review this notification 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. Your Zimmer Biomet sales representative will remove the affected product from your facility. 3. Complete Attachment 1 Certificate of Acknowledg |
| Quantity | 25 units |
| Distribution | International Distribution to countries of: Japan and Netherlands. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081546 | SMALL BONE LOCKING PLATING SYSTEM DePuy Orthopaedics, Inc., Aug 26, 2008 |