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Terminated

Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48

FDA Recall Z-1509-2014 · Posted 2014-04-25

Recalling FirmTeleflex Medical
Recall StatusTerminated
Product CodeNEW
Date Initiated2014-03-11
Date Terminated2017-09-25
Product Quantity3,072 ea.

Reason for Recall

Product does not meet minimum knot tensile strength requirements.

Firm Action

Consignees were notified by an Urgent Medical Device Recall Notification letter, dated 3/11/2014. The letter identified the affected product and the reason for recall. Customers were instructed to immediately discontinue use of and quarantine any affected product in stock. The affected product is to be returned; and the Recall Acknowledgement Form should be completed and faxed to the number provided regardless of whether customers have affected product in stock. Questions should be directed to a local sales rep or Customer Service at 1-866-246-6990.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution -- USA, including the state of MA, and the country of Germany

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K030212MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTUREGenzyme Biosurgery · 2003-03-27

Official Source

View FDA Recall →

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

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