Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

Terminated

Nonabsorbable Polypropylene Synthetic Suture-Deklene, DEK BL MF 0 TC-43 2N 48, Catalog #833-123

FDA Recall Z-1018-2007 · 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.

K930738SURGICAL SUTURES, PGL, GUT, DEKLENE, OPTHAMEND ETCDeknatel, Inc. · 1994-07-26K930739SUTURES POLYPROP., POLYETHELINE, NYLON & SILKDeknatel, Inc. · 1994-07-26

Official Source

View FDA Recall →

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

↑