Recall Z-1260-2011 ยท GDW Staple, Implantable
Ethicon, Inc.
Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device Product Code STRAP25. Intended for fixation of prosthetic material to soft tissues in various minimally invasive and open surgical procedures, such as hernia repairs.
| Date | Feb 18, 2011 (initiated Dec 29, 2010) |
| Status | Terminated |
| Reason | The Ethicon SecureStrap 5 mm Absorbable Strap Fixation Device may have the potential for the sterile barrier to be compromised due to a defect in the packaging. |
| Root cause | Pending |
| Action | Ethicon sent Urgent Voluntary Product Recall letters dated, December 28, 2010, to their customers on December 29, 2010 via UPS. The letter identified the affected product and described the reason for recall. Customers are to discontinue use and sampling immediately. They are to return the product using the enclosed prepaid shipping label along with the enclosed business reply card regardless of whether they have any affected product or not. Customers should contact 1-877-551-7147 or speak to their manager if they have questions regarding this recall. |
| Quantity | 4,110 |
| Distribution | Worldwide Distribution -- USA and Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K093845 | ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 ETHICON, Inc., Apr 7, 2010 |