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.
This recall has been terminated (originally issued August 26, 2010).
- Company
- Telefelx Medical
- Recall Initiated
- February 1, 2010
- Posted
- August 26, 2010
- Terminated
- April 19, 2011
- Recall Number
- Z-2286-2010
- Quantity
- 17 sales units (24 packs per sales unit/408 units)
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box.
Distribution
Worldwide Distribution: USA and Germany
Lot / Code Info
Catalog Number: EP4084N, Lot number: 02A0801449
Root Cause
Labeling mix-ups
Action Taken
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.