Recall Z-0922-2013 ยท NBH Accessories, Arthroscopic
Instratek, Incorporated
Endotrig Trigger Release Sterile Micro Hook Blade Product Usage: The blade is intended to release A-1 pulley in endoscopic trigger release procedures.
| Date | Mar 8, 2013 (initiated Sep 18, 2012) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | The firm decided to recall the product and sent notification letters to consignees dated 09/18/2012. |
| Quantity | 235 |
| Distribution | USA Nationwide Distribution including the states of: AZ, MI, NE, NV, and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.