Enforcement Report - Week of March 20, 2013
-
Back to Previous Page
Product Detail
| Product Description | Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures. |
|---|---|
| Recall Number | Z-0922-2013 |
| Classification | Class II |
| Code Info | Model number 1052; Lots M674180, MAKL170, M674200 |
| Product Distributed Qty | 235 |
| Reason For Recall | Instratek, Inc.has received multiple complaints of the 1052 Trigger Finger Release Blades which could not be advanced into the cannula through which it is used during trigger finger release procedures. |
Event Detail
| Event Id | 63551 |
|---|---|
| Product Type | Devices |
| Status | Ongoing |
| Recalling Firm | Instratek, Incorporated |
| City | Houston |
| State | TX | Country | US |
| Voluntary / Mandated | Voluntary: Firm Initiated |
| Recall Initiation Date | 2012-09-18 |
| Initial Firm Notification of Consignee or Public | Letter |
| Distribution Pattern | USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX. |
-
