VOLT Wrist Treatment System recallZ-1132-2026 · Tyber Medical · initiated Dec 19, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Tyber Medical or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The supplier manufactured anatomical left plates with an incorrect thread orientation.
FDA root cause category: Process control
What the company is doing
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.
Recall details
- Recall number
- Z-1132-2026
- Status
- Open, Classified
- Initiated by the company
- Dec 19, 2025
- Posted by the FDA
- Jan 20, 2026
- Recalling firm
- Tyber Medical
- Quantity
- 64 units
- Product code
- HRS
- FDA submissions
- K232652
- Distribution
- US Nationwide distribution in the state of PA.
Product 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
Code information (models, lots, serial numbers)
Model No: 02.426.691S; UDI-DI: 00196449020522; Lot Number: 291293
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- VOLT™ Wrist Treatment System 02.426.691STyber Medical, LLC · Plate, fixation, bone1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 98214).
- Z-1131-2026 · Open, ClassifiedBrand 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 …
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
How recalls are matched to devices · Editorial policy · Report an error on this page