FDAClass IIApril 24, 2024

Polysin recall

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

Why was Polysin recalled?

Complaints have been received with allegations of Incorrect Needle Curvature.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Model Number G503N; UDI: 00848782015115; Lot Codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, DA26LQG;

Product
POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
Recalling firm
SURGICAL SPECIALTIES
Quantity
2,459 units
Distribution
Domestic: AZ, CA, IL, MA, MD, MN, NJ, PA and TX. International: New Zealand.
Recall date
April 24, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (device)
Open FDA enforcement record Latest recalls