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Terminated

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

FDA Recall Z-1014-2007 · 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

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.

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.

K992088BONDEK PLUS POLYGLYCOLIC ACID SYNTHETIC ABSORBABLE SURGICAL SUTUREGenzyme Surgical Product (Genzyme Biosurgery) · 1999-09-03

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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