FDA Medical Device Recalls (openFDA)
Tyber Medical: Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No
- Recall number
- Z-1132-2026
- Recalling firm
- Tyber Medical
- Product
- Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/14Shaft/Left/Std/186mm Model/Catalog Number: 02.426.691S Product Description: 2 Column Distal Radius Plate - 6 Head, 14 Shaft, Standard Left - 186mm Component: No
- Status
- Open, Classified
- Initiated
- 2025-12-19
- Posted
- 2026-01-20
- Terminated
- not on file
- 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 the impacted devices that have been distributed. An RMA will be provided for the return of goods to Tyber Medical. 5. Complete the customer response form following this notification, or provide written notification, and return it to Tyber Medical via email correspondence to WeCare@exalta.com. A sub-notification letter was also provided to the distributor to provide to customers with the following actions: 1. Identify via product label and quarantine the impacted devices in your possession. 2. Complete the subsequent Acknowledgement and Receipt From and return it to DePuy Synthes via email correspondence, with Tyber Medical copied at WeCare@exalta.com 3. Return the impacted product to DePuy Synthes for replacement.
- Quantity
- 64 units
- Distribution
- US Nationwide distribution in the state of PA.
- Lot, serial or model codes
- Model No: 02.426.691S; UDI-DI: 00196449020522; Lot Number: 291293
- 510(k) numbers
- ["K232652"]
- PMA numbers
- not on file
- Product code
- HRS
- Firm FEI
- 3012966183
- Firm city
- Bethlehem
- Firm state
- PA
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28