Recall Z-0747-2019— Ethicon, Inc.

Name: FDA recall Z-0747-2019
Creator: U.S. Food and Drug Administration
Published: 2018-12-18

Class II · Terminated

Class II FDA medical device recall by Ethicon, Inc., initiated 2018-12-18, terminated 2020-05-29. It names one FDA 510(k) clearance: K946173. Product: PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.. Reason: The sutures inside the packaging are not the same size or type as indicated on the label..

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Terminated
Initiated: 2018-12-18
Terminated: 2020-05-29
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

PERMA-HAND Silk Suture Size 5, Black 30" (75cm) Double Armed LR Needles, Product Code 485T Product Usage: PERMA-HAND* suture is indicated for use in general soft tissue approximation and/or ligation, including use in cardiovascular, ophthalmic and neurological procedures.

Reason for recall

The sutures inside the packaging are not the same size or type as indicated on the label.

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