POLYSIN Surgical Sutures Recalled for Incorrect Needle Curvature Defect
Surgical Specialties is recalling POLYSIN (Polyglycolic Acid) surgical sutures due to incorrect needle curvature. This defect could affect proper suture placement during surgical procedures.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a surgical device with a manufacturing defect that poses a risk of harm. The defect (incorrect needle curvature) could affect proper surgical function, making this a risk-of-harm product. No illnesses or injuries have been reported.
Plain-English summary
Surgical Specialties is recalling POLYSIN (Polyglycolic Acid) surgical sutures (Model G503N, 5-0 size) due to incorrect needle curvature. Approximately 2,459 units have been distributed in the United States and New Zealand.
The defect involves improper needle curvature, which could affect proper suture placement and tissue closure during surgical procedures. Affected sutures were distributed in Arizona, California, Illinois, Massachusetts, Maryland, Minnesota, New Jersey, Pennsylvania, and Texas, as well as internationally to New Zealand.
Healthcare facilities should verify their inventory for the affected lot codes: C318TXK, C902CCF, D413FLD, D524ZOU, C725TAC, D215GJN, D503OCB, and DA26LQG. Affected sutures should be removed from use. Contact Surgical Specialties for return instructions and replacement product. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N
- Manufacturer
- SURGICAL SPECIALTIES
- Affected units
- 2,459
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (10)
- Model Number G503N
- UDI: 00848782015115
- Lot Codes: C318TXK
- C902CCF
- D413FLD
- D524ZOU
- C725TAC
- D215GJN
- D503OCB
- DA26LQG
Distribution
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