Z-1534-2024Class II

POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N

Name: Z-1534-2024 POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Creator: Surgical Specialties
Published: 2024-03-26
License: https://open.fda.gov/license/

Surgical Specialties Corp / initiated 2024-03-26 / Open, Classified / root cause: manufacturing process

FDA source

SURGICAL SPECIALTIES began a recall of POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N on 2024-03-26. FDA classified it as Class II and gives the reason as "Complaints have been received with allegations of Incorrect Needle Curvature". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1534-2024
Classification: Class II
Status: Open, Classified
Initiated: 2024-03-26
Posted: 2024-04-12
Recalling firm: Surgical Specialties Corp
Product: POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: Complaints have been received with allegations of Incorrect Needle Curvature.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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].
Quantity in commerce: 2,459 units
Distribution: Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
Product codes and lots: Model Number G503N; UDI: 00848782015115; Lot Codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, DA26LQG;

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1534-2024
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1534-2024	Class II	Ongoing	Voluntary: Firm initiated	2024-04-24	2024-04-12

Product code GAM

K965162Class IILukens Pga, (Polyglycolic Acid) Synthetic Absorbable Surgical Suture,coated, Braided-U.s.p.Lukens Medical Corp. / cleared 1997-02-12

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)