Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate 6Hd/10Shaft/Left/Std/139mm Mode

FDA device recall Z-1131-2026 · posted 2026-01-20 · Open, Classified

Recall details

Recalling firm

Tyber Medical

Reason for recall

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

Action taken

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.

Root cause

Process control

Status

Open, Classified

Product code

HRS

Quantity affected

100 units

Distribution

US Nationwide distribution in the state of PA.

Date initiated

2025-12-19

Date posted

2026-01-20

Location

Bethlehem, PA

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