BEUDAMED
    FDA Recall Open, Classified

    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: Z-1132-2026 · Initiated December 19, 2025

    Recall

    Recall Number
    Z-1132-2026
    Event Number
    98214
    Firm
    Tyber Medical
    FEI Number
    3012966183
    Product Code
    HRS
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 19, 2025
    Posted
    January 20, 2026
    Address
    83 S Commerce Way, Ste 310, Bethlehem, PA, 18017-8934

    Description

    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

    Reason

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

    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 [email protected] 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 [email protected]. 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 [email protected] 3. Return the impacted product to DePuy Synthes for replacement.

    Distribution

    US Nationwide distribution in the state of PA.

    Quantity

    64 units