FDA Device recall Z-1534-2024
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
- FDA Device
- Class II
- ongoing
- Published 2024-04-24
On 2024-04-24 the FDA classified a Class II recall of POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N by Surgical Specialties, citing complaints have been received with allegations of Incorrect Needle Curvature.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1534-2024 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2024-03-26 |
| Published | 2024-04-24 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Surgical Specialties |
| Distribution | AZ, CA, IL, MA, MD, MN, NJ, PA, TX |
Product
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Reason
Complaints have been received with allegations of Incorrect Needle Curvature.
Identifiers
| code_info | Model Number G503N; UDI: 00848782015115; Lot Codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, DA26LQG; |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1534-2024%22
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