Recall Z-2286-2010 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Telefelx Medical
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.
| Date | Aug 26, 2010 (initiated Feb 1, 2010) |
| Status | Terminated |
| Reason | Labeling error; The Bondek Suture product inside the box are of a different catalog number than labeled on the outer box. |
| 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 receive |
| Quantity | 17 sales units (24 packs per sales unit/408 units) |
| Distribution | Worldwide Distribution: USA and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K905482 | BONDEK POLYGLYCOLIC ACID SYNTHETIC ABSORB. SUTURE Pfizer Hospital Products Group, Inc., Mar 14, 1991 |