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
This recall has been terminated (originally issued July 17, 2007).
- Recall Initiated
- June 6, 2007
- Posted
- July 17, 2007
- Terminated
- March 14, 2008
- Recall Number
- Z-1016-2007
- Quantity
- 1920 units total for all types of sutures
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
The products may not meet their final specifications for suture diameter and/or strength which could lead to premature breakage.
Distribution
Worldwide-, USA including states of CO, FL, IL, IN, MA, and OH, and Countries of Canada, France and Germany
Lot / Code Info
NDR, MDK VI MF 0 TC43/HR2648, Catalog #833-137, Lot #2503061, 2503063, 2761528, 2761529 2694983, 3152877, 3169994, 2395967, 3163970 & 3232258; Monodek, MDK VI MF 2-0 FS-1 1N27, Catalog # M451V, Lot #2360982 & 2381287.
Root Cause
Other
Action Taken
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.