Z-1534-2024 Class II Ongoing
FDA device recall Z-1534-2024 was initiated by SURGICAL SPECIALTIES on March 26, 2024 and is designated Class II. Reason for recall: Complaints have been received with allegations of Incorrect Needle Curvature. The recall status is ongoing. Affected quantity: 2,459 units.
Recall Details
- Product Type
- Devices
- Report Date
- April 24, 2024
- Initiation Date
- March 26, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 2,459 units
Product Description
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Reason for Recall
Complaints have been received with allegations of Incorrect Needle Curvature.
Distribution Pattern
Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
Code Information
Model Number G503N; UDI: 00848782015115; Lot Codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, DA26LQG;