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U.S. Department of Health and Human Services

Class 2 Device Recall Universal Joints

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 Class 2 Device Recall Universal Jointssee related information
Date Initiated by FirmJune 02, 2025
Date PostedSeptember 03, 2025
Recall Status1 Open3, Classified
Recall NumberZ-2513-2025
Recall Event ID 97064
510(K)NumberK151580 
Product Classification Appliance, fixation, nail/blade/plate combination, multiple component - Product Code KTT
ProductMedshape Universal Joints, REF: DNE-9000-UJ
Code Information UDI-DI: 00810028397101 Lots : 001927, 002274, 002301, 002309, 002314, 002322, 002535, 009389, 090921, 32422, 5432, 5875, 61120, 90921
FEI Number 3007593722
Recalling Firm/
Manufacturer		 Medshape, INC.
1575 Northside Dr Nw Ste 440
Atlanta GA 30318-4211
For Additional Information ContactVladislava Zaitseva
800-321-9549 Ext. 11
Manufacturer Reason
for Recall		Bone external fixation system may have the pin that can become dislodged resulting in frame instability, the use of this product may cause a delay in surgery or a revision if the device is use.
FDA Determined
Cause 2		Process control
ActionOn 6/2/2025, recall notice were emailed to consignees who were asked to do the following: 1) Review your stock for the products and lot numbers for the items to be returned. 2) This notice needs to be passed on to all those within your organization or to any organization where the product has been transferred. 3) Complete acknowledgement and response form and return via email to FAsalessupport@enovis.com If you have any questions, contact firm at productsafety@enovis.com
Quantity in Commerce849
DistributionUS Nationwide distribution in the states of CA, IL, NJ, TX, FL, IN, OH, WI, VA, MA, SC, WA, NC, IA, MT, AZ, CO, NV, 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 = KTT
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