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U.S. Department of Health and Human Services

Class 2 Device Recall Perma Sharp Sutures

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 Class 2 Device Recall Perma Sharp Suturessee related information
Date Initiated by FirmSeptember 17, 2026
Date PostedNovember 03, 2026
Recall Status1 Open3, Classified
Recall NumberZ-0345-2027
Recall Event ID 100016
Product Classification Suture, absorbable, synthetic, polyglycolic acid - Product Code GAM
ProductGeneric Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN387V (HSI Item No. 600-9683); Product Description: Sterile, synthetic, absorbable, braided 6-0 violet polyglycolic acid (PGA) surgical suture, 18-inch length, with C-22 16.2 mm, 3/8-circle reverse-cutting needle. Component: N/A;
Code Information Model/Catalog Number: PSN387V (HSI Item No. 600-9683); UDI-DI: 10889950001254; Lot Numbers: 0925007HF, 0925020HF;
FEI Number 1000143438
Recalling Firm/
Manufacturer		 Henry Schein Inc.
41 Weaver Rd
Denver PA 17517-9308
For Additional Information ContactTracey Alexander
+1-631-4543003
Manufacturer Reason
for Recall		Products lack 510(k) clearance.
FDA Determined
Cause 2		Process control
ActionOn September 25, 2026, URGENT: MEDICAL DEVICE RECALL NOTIFICATION letters were sent to customers. ACTION: Please examine your inventory to determine whether you have affected product. If affected product is identified, immediately cease distribution and use, remove the product from available inventory, and follow the return instructions provided. The product must be returned within 30 days to Henry Schein s Returns Facility located at: 41 Weaver Rd, Denver, PA 17517.
Quantity in Commerce16
DistributionWorldwide distribution - U.S. Nationwide and the countries of Canada, Uganda, and the Cayman Islands.
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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