Tyber Medical recalls Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Pla…

The supplier manufactured anatomical left plates with an incorrect thread orientation.

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

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.

• FDA enforcement recordOfficial FDA database entry for Z-1132-2026
• FDA 510(k) clearance · K232652The device's official FDA premarket clearance record
• FDA device classification · HRSOfficial FDA classification for this device type
• CFR regulation · 21 CFR 888.3030The federal regulation governing this device
• FDA recall announcementSearch FDA.gov for the official press announcement
• Find Tyber MedicalSearch for the manufacturer's official notice
• News coverageRecent reporting on this recall and manufacturer
• openFDA data recordThe raw JSON record this page is built from

Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.