Modified Coated Vicryl* Rapide (Polyglactin 910) Suture

510(k) K033746

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

3 closed

Documents

FDA record

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Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Special	NumberK033746	Date18 Dec 2003Cleared	StatusActive

3 recalls · FDA

- Terminated Z-0693-2018 FDA Class II initiated 17 Aug 2017
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.
- Terminated Z-1608-2010 FDA Unclassified (pre-2012) initiated 20 Apr 2010
Channels in the packaging seal that can lead to suture degradation and loss of packaging integrity. Recall Z-0021-2009 was initiated in 2008. Ethicon had decided to recall all sutures product during the may to June 2007 timeframe.
- Terminated Z-0021-2009 FDA Unclassified (pre-2012) initiated 11 Aug 2008
Package defect compromised the integrity of the primary seal, which could lead to premature suture degradation and/or impair the sterile barrier of the product.

1 jurisdiction

United States — FDA 510(k) Active

510(k)