Recall Z-1247-2014 ยท ERL Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Stryker Instruments Div. of Stryker Corporation
2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resec
| Date | Mar 20, 2014 (initiated Mar 18, 2014) |
| Status | Terminated |
| Reason | Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the line on the affected part (P/N 5290-928-000, Lot #13280CG2) was a straight line without a number scale or logo. The line required for this part number includes a number scale that goes from 1cm 7cm. |
| Root cause | Employee error |
| Action | Stryker Instruments sent an Recall Notification dated March 18, 2014, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed if you have further distributed this product, please forward this letter and the attached Business Reply Form (BRF)to all affected locations. Please indicate each location on the BRF. A FedEx shipping label will be emailed to each account upon receipt of the signed Business Reply Form. This label will allow the account to return the product to be destroyed. A Business Re |
| Quantity | 90 units |
| Distribution | US Distribution including the states of NV, CA, WA, TN, OR, SD, ID, IN and CO., and Internationally to Malaysia |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K011381 | HUMMER IV MICRODEBRIDER SYSTEM Stryker Instruments, May 25, 2001 |