Auto Suture ProTack Fixation 5 mm Product Catalogue # 174006. Has application in endoscopic surgery procedures.
FDA device recall Z-1157-2010 · posted 2010-03-16 · Terminated
Recall details
- Recalling firm
- Covidien LP
- Reason for recall
- Fixation device may fail to fire and staple.
- Action taken
- Covidien notified accounts by "Urgent Medical Device Recall" letters dated 2/8/10. The letter identified the affected product and the reason for recall. Customers are to examine their inventory, and remove and return recalled lots. Customers are to follow the instructions provided in the letter to return the affected product. Questions should be directed to a Covidien Representative. On June 23, 2010, the firm issued a letter to expand the recall to include 5 additional lots.
- Root cause
- Process control
- Status
- Terminated
- Product code
- GDW
- Quantity affected
- 5,638 units
- Distribution
- Nationwide Distribution
- Date initiated
- 2010-02-08
- Date posted
- 2010-03-16
- Date terminated
- 2013-02-28
- Location
- North Haven, CT
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| AUTOSUTURE PROTACK; TACKER SYSTEM; ABSORBATACK FIXATION DEVICES (K090470) | Covidien | 2009-05-14 |
| AUTO SUTURE* MODIFIED ENDOSCOPIC FASCIA STAPLER** DEVICE (K963999) | United States Surgical, A Division of Tyco Healthc | 1996-11-27 |