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U.S. Department of Health and Human Services

Class 2 Device Recall Halyard TOTAL JOINT

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 Class 2 Device Recall Halyard TOTAL JOINTsee related information
Date Initiated by FirmJuly 09, 2026
Date PostedAugust 21, 2026
Recall Status1 Open3, Classified
Recall NumberZ-3010-2026
Recall Event ID 99527
Product Classification General surgery tray - Product Code LRO
ProductHalyard TOTAL JOINT Model/Catalog Number: MSBM036-03
Code Information Lot Code: Lot Number: 1673233 UDI: 10809160457887
FEI Number 1047429
Recalling Firm/
Manufacturer		 AVID Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information ContactMarlene Jones
+1-844-4259273
Manufacturer Reason
for Recall		Labeling Deficiency: The medical kit labeling fails to identify that the statlock component contains natural rubber latex.
FDA Determined
Cause 2		Labeling Change Control
ActionOn July 9, 2026 Avid Medical ( subsidiary of Owen & Minor) issued a Urgent: Medical Device correction notification to affected consignees. Avid Medical ask consignees to take the following actions: 1. Identify, segregate, and quarantine all impacted product identified. 2. Add warning labels to affected AVID kits to ensure all users are aware of the actions to discard the impacted component prior to use. A labeling template is enclosed for printing labels which can be affixed on all affected kits and cases in inventory. 3. Customers (end-users): If you received product from a distributor, please contact the distributor or your sales representative with any questions you may have. 4. Distributors: If any of the affected kits identified above were further distributed, please ensure all end-users are appropriately notified and maintain records of effectiveness. 5. Complete the attached Recall Response Form and return by July 24, 2026.
Quantity in Commerce130 KITS
DistributionUS Nationwide distribution in the states of MS, TX.
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.
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