POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part… recallZ-1534-2024 · Surgical Specialties · initiated Mar 26, 2024
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Surgical Specialties or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Complaints have been received with allegations of Incorrect Needle Curvature.
FDA root cause category: Process control
What the company is doing
On March 26, 2024 customers were sent URGENT MEDICAL DEVICE RECALL letters via email. The letters instructed customers to immediately examine your inventory and quarantine product subject to recall. In addition, if you may have further distributed this product, please identify your customers and notify them at once of the product recall. Your notification to your customers may be enhanced by including a copy of this recall notification letter and the acknowledgement form for product return. We kindly request the return of any affected product that may still be in your stock inventory, and we will replace the product at no charge. If you have any questions, contact [email protected].
Recall details
- Recall number
- Z-1534-2024
- Status
- Open, Classified
- Initiated by the company
- Mar 26, 2024
- Posted by the FDA
- Apr 12, 2024
- Recalling firm
- Surgical Specialties
- Quantity
- 2,459 units
- Product code
- GAM
- FDA submissions
- K965162
- Distribution
- Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
Product description
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Code information (models, lots, serial numbers)
Model Number G503N; UDI: 00848782015115; Lot Codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, DA26LQG;
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Hsm9 5-0 Und Br Pga 18"/45cm G503NSurgical Specialties México, S. de R.L. de C.V. · SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID1 recall0 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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