Recall Z-1509-2014 ยท NEW Suture, Surgical, Absorbable, Polydioxanone
Teleflex Medical
Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
| Date | Apr 25, 2014 (initiated Mar 11, 2014) |
| Status | Terminated |
| Reason | Product does not meet minimum knot tensile strength requirements. |
| Root cause | Under Investigation by 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. |
| Quantity | 3,072 ea. |
| Distribution | Worldwide Distribution -- USA, including the state of MA, and the country of Germany |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030212 | MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE Genzyme Biosurgery, Mar 27, 2003 |