Recall Z-1016-2007 ยท GAM Suture, Absorbable, Synthetic, Polyglycolic Acid
Teleflex Creek Dr
Suture Diameter/Strength specification failure: Various Polydioxanone Absorbable Surgical Sutures-NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V
| 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
| K030212 | MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE Genzyme Biosurgery, Mar 27, 2003 |