Z-1509-2014Class II

Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48

Name: Z-1509-2014 Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
Creator: Teleflex Medical
Published: 2014-03-11
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-03-11 / Terminated

FDA source

Teleflex Medical began a recall of Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48 on 2014-03-11. FDA classified it as Class II and gives the reason as "Product does not meet minimum knot tensile strength requirements". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1509-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-11
Posted: 2014-04-25
Terminated: 2017-09-25
Recalling firm: Teleflex Medical
Product: Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
Product code: NEW Suture, Surgical, Absorbable, Polydioxanone
Reason for recall: Product does not meet minimum knot tensile strength requirements.
FDA root cause: Under Investigation by firm
Action: Consignees were notified by an Urgent Medical Device Recall Notification letter, dated 3/11/2014. The letter identified the affected product and the reason for recall. Customers were instructed to immediately discontinue use of and quarantine any affected product in stock. The affected product is to be returned; and the Recall Acknowledgement Form should be completed and faxed to the number provided regardless of whether customers have affected product in stock. Questions should be directed to a local sales rep or Customer Service at 1-866-246-6990.
Quantity in commerce: 3,072 ea.
Distribution: Worldwide Distribution -- USA, including the state of MA, and the country of Germany
Product codes and lots: Product Code: 833-137, Batch: 02H1103434, 02H1200349, and 02K1201354.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1509-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1509-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-30	2014-04-24

Product code NEW

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 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)