Recall Z-0693-2018— Ethicon, Inc.

Name: FDA recall Z-0693-2018
Creator: U.S. Food and Drug Administration
Published: 2017-08-17

Class II · Terminated

Class II FDA medical device recall by Ethicon, Inc., initiated 2017-08-17, terminated 2019-05-08. It names one FDA 510(k) clearance: K033746. Product: Coated VICRYL RAPIDETM (Polyglactin 910) Suture. Reason: On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damage was identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent investigation, the suture also failed knot tensile strength testing..

Recalling firm: Ethicon, Inc.
Classification: Class II
Status: Terminated
Initiated: 2017-08-17
Terminated: 2019-05-08
Firm location: Somerville, NJ, United States

510(k) clearances named in this recall

1 on FDA's record

K033746 — MODIFIED COATED VICRYL* RAPIDE (POLYGLACTIN 910) SUTUREETHICON, Inc.·cleared 2003-12-18

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

Coated VICRYL RAPIDETM (Polyglactin 910) Suture

Reason for recall

On August 17, 2017, Ethicon had decided to initiate a medical device recall (removal) of the twenty-five (25) lots of VICRYL RAPIDETM (Polyglactin 910) Suture that were distributed to the field. During finished goods testing, a suture damage was identified on a lot of VICRYL RAPIDETM Suture. During the course of the subsequent investigation, the suture also failed knot tensile strength testing.

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