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
FDA Recall Z-1016-2007 · Posted 2007-07-17
Recalling FirmTeleflex Creek Dr
Recall StatusTerminated
Product CodeGAM
Date Initiated2007-06-06
Date Terminated2008-03-14
Product Quantity1920 units total for all types of sutures
Reason for Recall
The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
Firm 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.
Root Cause
Other
Distribution Pattern
Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.