Z-2828-2011

Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material 8886337272 Ti-Cron is...

Name: Z-2828-2011 Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material 8886337272 Ti-Cron is...
Creator: Covidien LP
Published: 2011-06-03
License: https://open.fda.gov/license/

Medtronic, Inc. / initiated 2011-06-03 / Terminated / root cause: manufacturing process

FDA source

Covidien LP began a recall of Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material 8886337272 Ti-Cron is intended for use in general soft tissue... on 2011-06-03. The reason FDA records is "Potential for the sterile barrier to be breached compromising the sterility of the product". 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-2828-2011
Status: Terminated
Initiated: 2011-06-03
Posted: 2011-07-15
Terminated: 2014-02-10
Recalling firm: Medtronic, Inc.
Product: Syneture Ti-Cron 1 Blue 5x18 HGS-22 D-Tach non-absorbable polyester sutures Material 8886337272 Ti-Cron is intended for use in general soft tissue approximation and/or ligation, including use in the cardiovascular, ophthalmic and neurological procedures
Product code: GAP Suture, Nonabsorbable, Silk
Reason for recall: Potential for the sterile barrier to be breached compromising the sterility of the product
Root cause tag: manufacturing process
FDA root cause: Equipment maintenance
Action: Covidien sent an URGENT MEDICAL DEVICE RECALL letter dated June 3, 2011 to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to immediately identify and quarantine all affected inventory. Distributors who further distributed the affected product were instructed to forward the letter to their customers who received the affected product. Customers were instructed to contact Covidien Customer Service at [email protected] or (800) 722- 8772, option 1, to obtain a Return Material Authorization (RMA) prior to returning the affected product. Customers were also asked to complete the attached product recall form in its entirety and fax the form to 203-822-6009 and include a copy with products being returned. If customers did not have any of the affected product they were to simply return the recall form via fax or email indicating they had zero units. For any questions regarding this recall customers were to contact their Covidien Representative or Covidien Quality Assurance at 203-492-5232.
Quantity in commerce: 648 units
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Australia, Canada, Denmark, France, Germany, Italy, Japan, Korea, and Singapore
Product codes and lots: Lot Code Number: D1D0037X

Product code GAP

K930591Class IITi-Cron and Dacron SuturesDavis & Geck, Inc. / cleared 1993-12-17

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)