Generic Name: Perma Sharp Sutures; Generic Name: Silk Nonabsorbable Surgical Suture; Model/Catalog Number: PSN683S (HSI Item No. 600-6411);…
Henry Schein Inc. · Products lack 510(k) clearance.
Open FDA's page for this record- Cfres ID
- 223145
- Product res number
- Z-0339-2027
- Event date initiated
- 2026-09-17
- Event date posted
- 2026-11-03
- Recall status
- Open, Classified
- Res event number
- 100016
- Product code
- GAP
- 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
- 140
- 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: Silk Nonabsorbable Surgical Suture; Model/Catalog Number: PSN683S (HSI Item No. 600-6411); Product Description: Sterile, natural, nonabsorbable, braided 4-0 black silk surgical suture, 18-inch length, with C-6 18.7 mm, 3/8-circle reverse-cutting needle. Component: N/A;
- Code info
Model/Catalog Number: PSN683S (HSI Item No. 600-6411); UDI-DI: 10889950001605; Lot Numbers: 0124001HF, 0124002HF, 0125009HF, 0125010HF, 0125026HF, 0125034HF, 0125040HF, 0125041HF
- 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, Nonabsorbable, Silk
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.5030
- Device class
- 2
- K number
- K041514, K930825, K172149, K000541, K964581, K042282, K904478, K001184, K080684, K761199, K981128, K241486, K162396, K993999, K904891, K053638, K232355, K930739, K180701, K160623, K905287, K024091, K760158, K012124, K221767, K930826, K990089, K931913, K020901, K943627, K994177, K942234, K222944, K003001, K071111, K980124, K023029, K760650, K982853, K905454 +1 more
- PMA number
- N84348, N80989, N84047, N11397, N85143
- Registration number
- 3006562124, 3027339877, 3004111573, 3013700547, 3017102971, 3029901632, 3006425876, 3006981798, 2523835, 1219930, 3009423112, 3027242374, 2648623, 3002692886, 3012494290, 1055236, 2648650, 1064584, 3032543753, 3014615644, 1058584, 3019269298, 3018052045, 1061927, 9710098, 3008912461, 3007109793, 3008483449, 3018094310, 3014592276, 3020983460, 1000274611, 2030624, 1061124, 3004365956, 3045855232, 3013187142, 1054241, 3006498370, 3009513193 +82 more
- FEI number
- 3006562124, 3027339877, 3004111573, 3013700547, 3017102971, 3029901632, 3006425876, 3002807993, 3006981798, 2523835, 1219930, 3009423112, 3027242374, 2648623, 3000302153, 3003040625, 3002692886, 3012494290, 3003495548, 1000112877, 2648650, 3032543753, 3014615644, 3019269298, 3018052045, 1000512168, 3008912461, 3007109793, 3008483449, 3018094310, 3014592276, 3020983460, 1000274611, 3004365956, 3045855232, 3013187142, 3006498370, 3009513193, 3003005156, 3010131137 +82 more