Recall Z-1534-2024— SURGICAL SPECIALTIES

Name: FDA recall Z-1534-2024
Creator: U.S. Food and Drug Administration
Published: 2024-03-26

Class II · Ongoing

Class II FDA medical device recall by SURGICAL SPECIALTIES, initiated 2024-03-26. It names one FDA 510(k) clearance: K965162. Product: POLYSIN (Polyglycolic Acid) suture, HSM9 5-0 BR PGA Part Number G503N. Reason: Complaints have been received with allegations of Incorrect Needle Curvature..

Recalling firm: SURGICAL SPECIALTIES
Classification: Class II
Status: Ongoing
Initiated: 2024-03-26
Firm location: Westwood, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K965162 — LUKENS PGA, (POLYGLYCOLIC ACID) SYNTHETIC ABSORBABLE SURGICAL SUTURE,COATED, BRAIDED-U.S.P.Lukens Medical Corp.·cleared 1997-02-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.