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U.S. Department of Health and Human Services

Class 2 Device Recall A.L.P.S. mvX

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 Class 2 Device Recall A.L.P.S. mvXsee related information
Date Initiated by FirmJanuary 21, 2025
Date PostedFebruary 21, 2025
Recall Status1 Open3, Classified
Recall NumberZ-1213-2025
Recall Event ID 96212
510(K)NumberK232652 
Product Classification Plate, fixation, bone - Product Code HRS
ProductA.L.P.S. mvX- ANATOMIC LAT FIB PLATE 8H LT: Anatomic Lateral Fibula Plate, 8-hole, Left Intended to bridge or otherwise stabilize bone fragments to facilitate healing. Model/Catalog Number: 770708081
Code Information UDI-DI 00196449015566; Lot Numbers 265784, 24043BU01, 261290
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		Complaints of the locking screw passing through the locking hole intra-operatively during use of the A.L.P.S. mvX Medial Tibia plates and Anatomic Lateral Fibula. r surgical delays have been reported with the use of the devices
FDA Determined
Cause 2		Process control
ActionTyber Medical issued Urgent Medical Device Recall letter on 1/24/25 via email to the Distributor. Letter states reason for recall, health risk and action to take: 1. Acknowledge the receipt of this communication via email correspondence to feedback@tybermed.com. 2. Further distribute this communication to all applicable parties and/or customers that possess the impacted inventory. 3. Identify via laser-marked lot number and quarantine the impacted plates under Zimmer Biomet s control that have not been distributed for sale. An RMA will be provided for the return of goods to Tyber Medical for further inspection. 4. Identify via laser-marked lot number and quarantine the impacted plates that have been distributed. An RMA will be provided for the return of goods to Tyber Medical for further inspection. 5. Complete the customer response form located in Appendix 2 and return it to Tyber Medical via email correspondence to feedback@tybermed.com.
Quantity in Commerce214 units
DistributionNationwide
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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