Various Sizes of Sterile Polygycolic Acid Synthetic Surgical Sutures -Bondek, BON+ BG BR 1 HRX27 1N70CM, Catalog # EP1082N, Bondek, BON+ BG BR 2-0 HR26+ 1RN4X45CM, Catalog # EP8027XN, Bondek, BON+ BG BR 0 12X45CM, Catalog # EP8656N, Bondek, BON+ BG BR 2 12X45CM, Catalog # EP8658N
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-1014-2007
- Quantity
- 1920 units total for all types of sutures
- Firm Location
- Durham, NC
- Official Source
- View on FDA website ↗
Reason for Recall
Suture Diameter/Strength specification failure: 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+ BG BR 1 HRX27 1N70CM, Catalog # EP1082N, Lot #2535750; Bondek, BON+ BG BR 2-0 HR26+ 1RN4X45CM, Catalog # EP8027XN Bondek, BON+ BG BR 0 12X45CM, Catalog # EP8656N, Lot #2297631; Bondek, BON+ BG BR 2 12X45CM, Catalog # EP8658N, Lot #2396240, 2498757 & 2511511.
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.