Z-0346-2027

Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog...

Name: Z-0346-2027 Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog...
Creator: Henry Schein Inc.
Published: 2026-09-17
License: https://open.fda.gov/license/

Henry Schein Inc. / initiated 2026-09-17 / Open, Classified

FDA source

Recall record

Recall number: Z-0346-2027
Status: Open, Classified
Initiated: 2026-09-17
Posted: 2026-11-03
Recalling firm: Henry Schein Inc.
Product: Generic Name: Perma Sharp Sutures; Generic Name: Polypropylene Nonabsorbable Surgical Suture; Model/Catalog Number: PSN8695P (HSI Item No. 600-9795); Product Description: Sterile, synthetic, nonabsorbable, monofilament 6-0 blue polypropylene surgical suture, 18-inch length, with C-3 premium surgical needle. Component: N/A;
Product code: GAW Suture, Nonabsorbable, Synthetic, Polypropylene
Reason for recall: Products lack 510(k) clearance.
FDA root cause: Process control
Action: On 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 commerce: 23
Distribution: Worldwide distribution - U.S. Nationwide and the countries of Canada, Uganda, and the Cayman Islands.
Product codes and lots: Model/Catalog Number: PSN8695P (HSI Item No. 600-9795); UDI-DI: 10889950001926; Lot Numbers: 0624001HF, 0624004HF, 0624010HF;

Product code GAW

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-28, the FDA export date for this dataset. Page last changed 2026-11-06. View this recall on fda.gov (opens on fda.gov)