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U.S. Department of Health and Human Services

Class 2 Device Recall Halyard ANTERIOR HIP PACK

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 Class 2 Device Recall Halyard ANTERIOR HIP PACKsee related information
Date Initiated by FirmSeptember 08, 2026
Date PostedOctober 22, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0282-2027
Recall Event ID 99968
Product Classification General surgery tray - Product Code LRO
ProductHalyard ANTERIOR HIP PACK. Model/Catalog Number: SOAH31.
Code Information Model/Catalog Number: SOAH31. UDI-DI: 10809160512890. Lot Code: Lot Number: 1689215. Expiration Date: 11/06/2026.
FEI Number 1047429
Recalling Firm/
Manufacturer		 AVID Medical, Inc.
9000 Westmont Dr
Toano VA 23168-9351
For Additional Information ContactMarlene Jones
+1-470-2804277
Manufacturer Reason
for Recall		A non-sterile component was piggybacked and incorrectly placed outside of the sterile barrier and not subjected to EO sterilization per kit specifications.
FDA Determined
Cause 2		Process control
ActionAVID Medical notified consignees on about 09/08/2026 via emailed "URGENT: MEDICAL DEVICE CORRECTION" letter. Consignees were instructed to identify, segregate, and quarantine all impacted kits identified, and to not use the impacted component located in the piggybacked portion of the convenience kit. Customers were also instructed to add warning labels to affected kits to ensure all users are aware of the actions to remove and discard the impacted component prior to use. distributors were instructed to notify consignees if affected units were further distributed. Additionally, consignees were requested to complete and return the Recall Response Form.
Quantity in Commerce56 kits
DistributionUS Nationwide distributor in the state of Arizona.
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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