Z-1296-2014Class II

Sutures, Non-absorbable, Silk, Sterile, Rx only

Name: Z-1296-2014 Sutures, Non-absorbable, Silk, Sterile, Rx only
Creator: Teleflex Medical
Published: 2014-03-11
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2014-03-11 / Terminated / root cause: manufacturing process

FDA source

Teleflex Medical began a recall of Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible... on 2014-03-11. FDA classified it as Class II and gives the reason as "The products are being recalled because they did not meet minimum needle attachment strength requirements". 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-1296-2014
Classification: Class II
Status: Terminated
Initiated: 2014-03-11
Posted: 2014-03-26
Terminated: 2017-08-15
Recalling firm: Teleflex Medical
Product: Sutures, Non-absorbable, Silk, Sterile, Rx only, Product Usage: Natural non-absorbable silk surgical suture is a non-absorbable, sterile, flexible multifilament thread composed of an organic protein called fibroin. This protein is derived from the domesticated species Bombyx mori (B. mori) of the family Bombycidae. Natural non-absorbable silk surgical suture is indicated for use in soft tissue approximation. Natural non-absorbable silk surgical suture meets the United States Pharmacopeia (U.S.P.) monograph requirements for Non-absorbable Surgical Suture (class I). Natural non-absorbable silk surgical suture may be braided or twisted; it may be provided uncoated or coated; and it may be undyed or dyed with an FDA listed color additive.
Product code: GAT Suture, Nonabsorbable, Synthetic, Polyethylene
Reason for recall: The products are being recalled because they did not meet minimum needle attachment strength requirements.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Teleflex sent an Urgent Medical Device Recall Notification letter dated March 11, 2014 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to return all affected product to Teleflex Medical per the instructions provided in the letter. Customers were asked to complete the enclosed Recall Acknowledgment Form and fax it 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: Total 32,271 ea.
Distribution: Worldwide Distribution - U.S. Nationwide and the countries of Canada, Germany, and Ireland
Product codes and lots: Product Code: X-6371M5, Lot numbers: 02E0801603

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1296-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1291-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1292-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1293-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1294-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1295-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25
Z-1296-2014	Class II	Terminated	Voluntary: Firm initiated	2014-04-02	2014-03-25

Product code GAT

K021019Class IICottony II, Silky II Polydek & Tevdek II Polyester SutureGenzyme Corp. / cleared 2002-06-18

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)