Z-1016-2007

Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI...

Name: Z-1016-2007 Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI...
Creator: Teleflex Creek Dr
Published: 2007-06-06
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2007-06-06 / Terminated

FDA source

Teleflex Creek Dr began a recall of Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK... on 2007-06-06. The reason FDA records is "The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1016-2007
Status: Terminated
Initiated: 2007-06-06
Posted: 2007-07-17
Terminated: 2008-03-14
Recalling firm: Teleflex Medical
Product: Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
FDA root cause: Other
Action: Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical.
Quantity in commerce: 1920 units total for all types of sutures
Distribution: Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
Product codes and lots: NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Lot #2503061, 2503063, 2761528, 2761529 2694983, 3152877, 3169994, 2395967, 3163970 & 3232258; Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V, Lot #2360982 & 2381287.

Product code GAM

K030212Class IIMonodek Synthetic Absorbable Surgical SutureGenzyme Biosurgery / cleared 2003-03-27

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)