Z-0347-2014Class II

Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910)...

Name: Z-0347-2014 Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910)...
Creator: Riverpoint Medical, LLC
Published: 2012-12-13
License: https://open.fda.gov/license/

Riverpoint Medical, LLC / initiated 2012-12-13 / Terminated / root cause: manufacturing process

FDA source

Riverpoint Medical, LLC began a recall of Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA... on 2012-12-13. FDA classified it as Class II and gives the reason as "Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0347-2014
Classification: Class II
Status: Terminated
Initiated: 2012-12-13
Posted: 2013-11-18
Terminated: 2013-11-21
Recalling firm: Riverpoint Medical, LLC
Product: Polyglycolic-Lactic Acid Absorbable Surgical Suture Label reads in part "Coated VILET *** (Polyglacin 910) Suture UNDYED BRANDED V423 *** Riverpoint ***" PGLA surgical suture is indicated for use in general soft tissue approximation and/or ligation, including use in opthalmic procedures, but not for use in cardiovascular and neurological tissues
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
Reason for recall: Riverpoint Medical is recalling PGLA Surgical Suture (Vilet) because the label indicates the suture is undyed and it is actually a violet colored suture.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Riverpoint sent an Urgent Medical Device Recall letter in December 2012 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were requested to review their inventory and immediately quarantine the product in question, if found. In addition, if they have further distributed the recalled product, the consignees were advised to identify their customers and notify them of this product recall. All affected product is to be returned to Riverpoint Medical. Consignees were asked to call 503-517-8001 to return recalled product and request a credit or replacement. For questions regarding this recall call 503-517-8001.
Quantity in commerce: 1932 pieces
Distribution: US Distribution in the states of: AZ, FL, and TX.
Product codes and lots: Lot 120716-01

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0347-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0347-2014	Class II	Terminated	Voluntary: Firm initiated	2013-11-27	2013-11-18

Product code NEW

K100461Class IIPdm, Vilet, Vilet Quick, Mono Q, Plain Gut:# 6 Chromic GutRiverpoint Medical / cleared 2010-07-08

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)