Recall Z-0492-2015— Ethicon, Inc.

Name: FDA recall Z-0492-2015
Creator: U.S. Food and Drug Administration
Published: 2014-10-17

Class II · Terminated

Class II FDA medical device recall by Ethicon, Inc., initiated 2014-10-17, terminated 2015-08-14. It names one FDA 510(k) clearance: K946173. Product: Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.. Reason: Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products..

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Terminated
Initiated: 2014-10-17
Terminated: 2015-08-14
Firm location: Somerville, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K946173 — STAINLESS STEEL, GUT, POLY (GLYCOLIDE/L-LACTIDE) POLYAMIDE, POLYPROPYLENE, POLY (ETHYLENE TEREPHTHALATE) AND SILKETHICON, Inc.·cleared 1995-01-09

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

Ethicon PERMA-HAND Silk siliconized black braided 10 strands per packet Ethicon LLC- Made in USA.

Reason for recall

Ethicon is unable to ensure that PERMA-HAND silk suture (siliconized black braid) meets the expected sterility assurance level for sterile products.

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