FDA Medical Device Recalls (openFDA)
Teleflex Creek Dr: 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
- Recall number
- Z-1014-2007
- Recalling firm
- Teleflex Creek Dr
- Product
- 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
- Status
- Terminated
- Initiated
- 2007-06-06
- Posted
- 2007-07-17
- Terminated
- 2008-03-14
- Reason
- 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.
- 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
- Lot, serial or model codes
- 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.
- 510(k) numbers
- ["K992088"]
- PMA numbers
- not on file
- Product code
- GAM
- Firm FEI
- 3005747797
- Firm city
- Durham
- Firm state
- NC
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28