Generic Name: Perma Sharp Sutures; Generic Name: PGA Absorbable Surgical Suture; Model/Catalog Number: PSN387V (HSI Item No. 600-9683); Pro…
Henry Schein Inc. · Products lack 510(k) clearance.
Open FDA's page for this record- Cfres ID
- 223151
- Product res number
- Z-0345-2027
- Event date initiated
- 2026-09-17
- Event date posted
- 2026-11-03
- Recall status
- Open, Classified
- Res event number
- 100016
- Product code
- GAM
- Code info
- Model/Catalog Number: PSN387V (HSI Item No. 600-9683); UDI-DI: 10889950001254; Lot Numbers: 0925007HF, 0925020HF;
- Firm FEI number
- 1000143438
- Recalling firm
- Henry Schein Inc.
- Address 1
- 41 Weaver Rd
- City
- Denver
- State
- PA
- Postal code
- 17517-9308
- Additional info contact
- Tracey Alexander +1-631-4543003
- Reason for recall
- Products lack 510(k) clearance.
- Root cause description
- Process control
- Product quantity
- 16
- Distribution pattern
- Worldwide distribution - U.S. Nationwide and the countries of Canada, Uganda, and the Cayman Islands.
- Product description
Generic 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;
- 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.
- Harmonized identifiers (openFDA)
- Device name
- Suture, Absorbable, Synthetic, Polyglycolic Acid
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4493
- Device class
- 2
- K number
- K041515, K153611, K944937, K232372, K053636, K021767, K945285, K150717, K032586, K221744, K013177, K081002, K060828, K022715, K072863, K123836, K970863, K022269, K072229, K212810, K915835, K171001, K173779, K130737, K253852, K160564, K990951, K944110, K123409, K200392, K192580, K171494, K072859, K964345, K050845, K984374, K032698, K014021, K041806, K142810 +110 more
- PMA number
- N18387, N16881, P840051
- Registration number
- 3006562124, 3004111573, 3017102971, 3029901632, 3006425876, 3006981798, 2183744, 1219930, 3010860245, 2648623, 3002692886, 3012494290, 1055236, 2648650, 1064584, 1423662, 3013548553, 3032543753, 3014615644, 1058584, 3018052045, 9710098, 2528981, 3019924, 3005941719, 3008912461, 3045857207, 3015542154, 9617547, 1320468, 3014592276, 3020983460, 3018094310, 2030624, 1061124, 1000274611, 3004365956, 3045855232, 1319660, 3013187142 +107 more
- FEI number
- 3006562124, 3004111573, 3017102971, 3029901632, 3006425876, 3002807993, 3006981798, 2183744, 1219930, 3010860245, 2648623, 3003040625, 3002692886, 3012494290, 3003495548, 1000112877, 2648650, 3013548553, 3032543753, 3014615644, 3018052045, 1000512168, 2528981, 3019924, 3008912461, 3045857207, 3015542154, 3018094310, 3014592276, 3020983460, 1000274611, 3004365956, 3045855232, 3002807111, 3013187142, 1720929, 3015489699, 1221934, 3003595343, 3003005156 +107 more