Monodek Violet Synthetic Absorbable Surgical Sutures, MF 0 TC43/HR26 48
FDA device recall Z-1509-2014 · posted 2014-04-25 · Terminated
Recall details
- Recalling firm
- Teleflex Medical
- Reason for recall
- Product does not meet minimum knot tensile strength requirements.
- Action taken
- 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
- Status
- Terminated
- Product code
- NEW
- Quantity affected
- 3,072 ea.
- Distribution
- Worldwide Distribution -- USA, including the state of MA, and the country of Germany
- Date initiated
- 2014-03-11
- Date posted
- 2014-04-25
- Date terminated
- 2017-09-25
- Location
- Research Triangle Park, NC
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MONODEK SYNTHETIC ABSORBABLE SURGICAL SUTURE (K030212) | Genzyme Biosurgery | 2003-03-27 |