Recall Z-1131-2026 ยท HRS Plate, Fixation, Bone
Tyber Medical
Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Model/Catalog Number: 02.426.681S Product Description: 2 Column Distal Radius Plate - 6 Head, 10 Shaft, Standard Left - 139mm
| Date | Jan 20, 2026 (initiated Dec 19, 2025) |
| Status | Open, Classified |
| Reason | The supplier manufactured anatomical left plates with an incorrect thread orientation. |
| Root cause | Process control |
| Action | On December 19, 2025, an URGENT MEDICAL DEVICE REMOVAL NOTIFICATION email was sent to their only customer. Actions to be taken: 1. Acknowledge the receipt of this communication via email correspondence to WeCare@exalta.com 2. Further distribute this communication through notifying the accounts that have received the identified devices. 3. Identify via product label and quarantine the impacted devices under DePuy Synthes control all devices that have not been distributed for sale. An RMA will be provided for the return of goods to Tyber Medical. 4. Identify via product label and quarantine th |
| Quantity | 100 units |
| Distribution | US Nationwide distribution in the state of PA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K232652 | Anatomical Plating System (various) Tyber Medical, LLC, Dec 13, 2023 |