Z-1535-2014Class II

Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture...

Name: Z-1535-2014 Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture...
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 Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code... on 2014-03-11. FDA classified it as Class II and gives the reason as "The product did not meet minimum and/or average minimum Teleflex resorption strength requirements". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1535-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-11
Posted: 2014-05-01
Terminated: 2016-03-29
Recalling firm: Teleflex Medical
Product: Dekna-lok, 1 x 17.78 cm, Violet Braided Polyglycolic Acid Coated Suture, Synthetic Absorbable Surgical Suture USP, Rx Only, Sterile. Teleflex Product Code: 200101-01.
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: The product did not meet minimum and/or average minimum Teleflex resorption strength requirements.
FDA root cause: Other
Action: Teleflex Medical sent an Urgent Medical Device Recall Notification dated March 11, 2014. The letter identified the affected product, problem and actions to be taken. Custmers were instructed to return all affected product to Teleflex Medical per the instructions on the Urgent Recall Notice. Customers were asked to complete the enclosed Recall Acknowledgement Form and fax to 1-866-804-9881, Attn: Customer Service. For questions contact your local sales representative or Customer Service at 1-866-246-6990
Quantity in commerce: 7,380 ea (total)
Distribution: Worldwide Distribution - US Nationwide in the states of CA, CO, GA, LA, IL, MA, MI, MN, MO, NC, and in the countries of Ireland and Singapore.
Product codes and lots: Product Code: 200101-01, Lot # 02F0801290 and Product Code: BP1000V2L, Lot numbers: 02C1003535 & 02F1000711.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1535-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1534-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-05-01
Z-1535-2014	Class II	Terminated	Voluntary: Firm initiated	2014-05-07	2014-05-01

Product code GAM

K992088Class IIBondek Plus Polyglycolic Acid Synthetic Absorbable Surgical SutureGenzyme Surgical Product (Genzyme Biosurgery) / cleared 1999-09-03

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)