Recall Z-2042-2016— SSC- Surgical Specialties Corporation

Name: FDA recall Z-2042-2016
Creator: U.S. Food and Drug Administration
Published: 2016-05-20

Class II · Terminated

Class II FDA medical device recall by SSC- Surgical Specialties Corporation, initiated 2016-05-20, terminated 2016-08-12. It names one FDA 510(k) clearance: K904906. Product: Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N. Reason: Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture..

Recalling firm: SSC- Surgical Specialties Corporation
Classification: Class II
Status: Terminated
Initiated: 2016-05-20
Terminated: 2016-08-12
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K904906 — SHARPOINT POLYPROPYLENE NONABSORB SURG SUTURES USPChathamborough Research Group, Inc.·cleared 1990-12-24

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

Sharpoint Polypropylene Blue Monofilament 6"/15cm 9-0 USP, Product No. J2558N

Reason for recall

Surgical Specialties is recalling Sharpoint Polyproplyene Blue Monofilament 6"/15cm 9-0 USP because it may contain Black Nylon 9-0 suture.

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