Z-2286-2010

Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex...

Name: Z-2286-2010 Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex...
Creator: Telefelx Medical
Published: 2010-02-01
License: https://open.fda.gov/license/

Teleflex Medical / initiated 2010-02-01 / Terminated / root cause: labeling and UDI

FDA source

Telefelx Medical began a recall of Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex Medical. Bondek and Bondek Plus Synthetic Absorbable... on 2010-02-01. The reason FDA records is "Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-2286-2010
Status: Terminated
Initiated: 2010-02-01
Posted: 2010-08-26
Terminated: 2011-04-19
Recalling firm: Teleflex Medical
Product: Deknatel Bondek Plus Polyglycolic Absorbable Surgical Sutures, Bon+BG BR 3-0 DSL 19 1N (45cm), Teleflex Medical. Bondek and Bondek Plus Synthetic Absorbable Surgical Sutures intended uses are in general surgical procedures where general soft tissue approximation and/or ligation are performed, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.
Product code: GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Reason for recall: Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Teleflex Medical issued consignees a "Urgent Medical Device Recall" letter dated February 1, 2010. Distributors were instructed to forward the letter to their consignees to retrieve relevant product from those locations. The letter described the packaging issue and potential impact. Customers were instructed to immediately discontinue use and quarantine any identified products, complete and fax the Recall Acknowledgement Form to 866-804-9881, in order to receive a Return Goods Authorization (RGA) Number, and then return the product to Teleflex Medical for replacement. Affected products received by Teleflex Medical will be destroyed upon receipt.
Quantity in commerce: 17 sales units (24 packs per sales unit/408 units)
Distribution: Worldwide Distribution: USA and Germany
Product codes and lots: Catalog Number: EP4084N, Lot number: 02A0801449

Product code GAM

K905482Class IIBondek Polyglycolic Acid Synthetic Absorb. SuturePfizer Hospital Products Group, Inc. / cleared 1991-03-14

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)