Recalls / —

—#126704

Product

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

FDA product code

NEW — Suture, Surgical, Absorbable, Polydioxanone

Device class

Class 2

Medical specialty

General, Plastic Surgery

510(k) numbers

K030212

Affected lot / code info

Product Code: 833-137, Batch: 02H1103434, 02H1200349, and 02K1201354.

Why it was recalled

Product does not meet minimum knot tensile strength requirements.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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.

Recalling firm

Firm

Teleflex Medical

Address

2917 Weck Dr., Research Triangle Park, North Carolina 27709

Distribution

Distribution pattern

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

Timeline

Recall initiated

2014-03-11

Posted by FDA

2014-04-25

Terminated

2017-09-25

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #126704. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.