Device product
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Z-1534-2024
Product summary
- Event
- Event 94237
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,459 units
- Official record key
device-enforcement:Z-1534-2024
Official wording
Reason: Complaints have been received with allegations of Incorrect Needle Curvature.
Code information: Model Number G503N; UDI: 00848782015115; Lot Codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, DA26LQG;
Distribution pattern: Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
Derived failure modes
-
Unknown
Complaints have been received with allegations of Incorrect Needle Curvature.