FDA recall Z-0693-2018

Product

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.

Distribution

Nationally

Key facts

Status

Terminated

Initiation date

2017-08-17

Report date

2018-03-07

Termination date

2019-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Somerville, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0693-2018