FDAFDA · Food and drugs·Recall number Z-1534-2024
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Published April 24, 2024 · Recall initiated: March 26, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Complaints have been received with allegations of Incorrect Needle Curvature.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- SURGICAL SPECIALTIES
- Distributor
- Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
- Lot
- Model Number G503N; UDI: 00848782015115; Lot Codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, DA26LQG;
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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