Z-1132-2026Class II

Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate...

Name: Z-1132-2026 Brand Name: VOLT" Wrist Treatment System Product Name: 2.4/2.7 2Column Dist Radius Plate...
Creator: Tyber Medical
Published: 2025-12-19
License: https://open.fda.gov/license/

Tyber Medical / initiated 2025-12-19 / Open, Classified / root cause: manufacturing process

FDA source

Tyber Medical began a recall of 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... on 2025-12-19. FDA classified it as Class II and gives the reason as "The supplier manufactured anatomical left plates with an incorrect thread orientation". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1132-2026
Classification: Class II
Status: Open, Classified
Initiated: 2025-12-19
Posted: 2026-01-20
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
Product code: HRS Plate, Fixation, Bone
Reason for recall: The supplier manufactured anatomical left plates with an incorrect thread orientation.
Root cause tag: manufacturing process
FDA 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 [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.
Quantity in commerce: 64 units
Distribution: US Nationwide distribution in the state of PA.
Product codes and lots: Model No: 02.426.691S; UDI-DI: 00196449020522; Lot Number: 291293

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1132-2026
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1131-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-20
Z-1132-2026	Class II	Ongoing	Voluntary: Firm initiated	2026-01-28	2026-01-20

Product code HRS

K232652Class IIAnatomical Plating System (various)Tyber Medical, LLC / cleared 2023-12-13

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)