Ethicon, Inc. recalls Coated VICRYL RAPIDETM (Polyglactin 910) Suture

Recall date

August 17, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0693-2018

FDA classification

Class II

Brand / firm

Ethicon, Inc.

Sold / distributed

Nationally

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Coated VICRYL RAPIDETM (Polyglactin 910) Suture