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
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-1012-2007
- 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
Bondek, BON GN BR 0 GR19 1N7 USAB, Catalog #0500197-2, Lot numbers: 3244075; Bondek, BON GN BR 2-0 GRB 121N7"USAB, Catalog #0520127-2, Lot #2361002; Bondek, BON GNBR 3-0 DR17 1N7"USAB, Catalog #0530177-2, Lot #2401863 & 2498856; Bondek, BON GN BR 2-0 C-2/CST-4336, Catalog #833-136, Lot #2443985 & 3080258; Bondek, BON GN BR 0 TC-43 2N 48, Catalog #833-213, Lot #2528539, & 3163971; Bondek, BON GN BR 2-0 HS 36 1N27, Catalog # B2098G, Lot #2554480.
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.