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U.S. Department of Health and Human Services

Class 2 Device Recall BIORAPTOR Suture Anchor

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 Class 2 Device Recall BIORAPTOR Suture Anchorsee related information
Date Initiated by FirmOctober 29, 2024
Date PostedNovember 29, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0581-2025
Recall Event ID 95654
510(K)NumberK071586 K152566 
Product Classification Fastener, fixation, nondegradable, soft tissue - Product Code MBI
ProductBIORAPTOR Suture Anchors. Tendon/ligament, non-bioabsorbable bone anchor.
Code Information Part No. 72201541, 72201542, 72203280, 72203281; UDI-DI: 03596010595072, 03596010595089, 03596010656452, 03596010656469; Batch No. 2146369, 2151242, 2151690, 2154691, 2153489, 2151692.
Recalling Firm/
Manufacturer		 Smith & Nephew Inc.
150 Minuteman Rd
Andover MA 01810-1031
Manufacturer Reason
for Recall		Sterile barrier breach due to inadequate packaging design that could not hold the geometry of the device.
FDA Determined
Cause 2		Package design/selection
ActionAn URGENT MEDICAL DEVICE RECALL NOTICE dated 10/29/24 was mailed to consignees. This notification instructed consignees to inspect their inventory for affected devices and quarantine them immediately. If product was further distributed consignees are to notify their customers of this recall and ensure recall actions are completed. Consignees are to complete the provided response form to facilitate the return of devices and email the completed form to FieldActions@smith-nephew.com. Consignees who do not have product on hand are to complete and return the recall response form as well. Any questions about this recall are to be emailed to FieldActions@smith-nephew.com.
Quantity in Commerce2,156 units
DistributionWorldwide - US Nationwide distribution in the states of AK, AL, IL, IN, KY, MD, MN, NC, NE, NH, NJ, TX and the countries of CA, CL, CN, EC, ES, GB, KZ, NO, PE, PL, RU, TR.
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 = MBI
510(K)s with Product Code = MBI
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