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U.S. Department of Health and Human Services

Class 2 Device Recall VOLT" Wrist Treatment System

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 Class 2 Device Recall VOLT" Wrist Treatment Systemsee related information
Date Initiated by FirmDecember 19, 2025
Date PostedJanuary 20, 2026
Recall Status1 Open3, Classified
Recall NumberZ-1132-2026
Recall Event ID 98214
510(K)NumberK232652 
Product Classification Plate, fixation, bone - Product Code HRS
ProductBrand 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 Model No: 02.426.691S; UDI-DI: 00196449020522; Lot Number: 291293
FEI Number 3012966183
Recalling Firm/
Manufacturer		 Tyber Medical
83 S Commerce Way Ste 310
Bethlehem PA 18017-8934
For Additional Information ContactZachary Bloshuk
1-866-7610933
Manufacturer Reason
for Recall		The supplier manufactured anatomical left plates with an incorrect thread orientation.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce64 units
DistributionUS Nationwide distribution in the state of PA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database510(K)s with Product Code = HRS
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