Recall Z-1012-2007 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Teleflex Creek Dr
Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Suture: Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136,Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G
| Date | Jul 17, 2007 (initiated Jun 6, 2007) |
| Status | Terminated |
| Reason | The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage. |
| Root cause | Other |
| Action | Consignees were notified by letter on/about 06/07/2007. They were advised to cease use, remove and quarantine all affected product immediately. Affected products are to be returned to Teleflex Medical. An Acknowledgement & Stock form was included to be completed and returned via fax to Teleflex Medical. |
| Quantity | 1920 units total for all types of sutures |
| Distribution | Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992088 | BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTURE Genzyme Surgical Product (Genzyme Biosurgery), Sep 3, 1999 |