Recall archive / FDA device enforcement
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N — FDA record Z-1534-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 26, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
- Reason
- Complaints have been received with allegations of Incorrect Needle Curvature.
- Classification
- Class II
- Recalling firm
- SURGICAL SPECIALTIES
- Quantity
- 2,459 units
- Agency-reported status
- Ongoing
- Source record identifier
- Z-1534-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Model Number G503N; UDI: 00848782015115; Lot Codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, DA26LQG; |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
Dates in the source
- Report date
- Apr 24, 2024
- Recall initiation date
- Mar 26, 2024
- Center classification date
- Apr 12, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.