Recall Z-0573-2008 ยท GEI Electrosurgical, Cutting & Coagulation & Accessories
Stryker Endoscopy
Stryker Disposable StrykeProbe 32cm L- Tip, Ref: 250-070-550, Electrosurgical Suction Tip, Stryker Endoscopy, San Jose, CA 95138.
| Date | Mar 5, 2008 (initiated Nov 16, 2007) |
| Status | Terminated |
| Reason | Cannot connect: Tips have electrodes that are too large to fit monopolar cables and are unusable. |
| Root cause | Device Design |
| Action | Stryker notified their sales representatives by phone. Stryker sent all consignees a Product Advisory Notice dated November 19, 2007, and verbally notified them of the recall via telephone. A response form with return postage was sent with the notice. The letter requested the hospitals to quarantine and return the product to Stryker. |
| Quantity | 59 boxes of 6 units (354 total) |
| Distribution | Nationwide Distribution. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K052141 | STRYKER STILETTO ELECTROSURGICAL PROBE Stryker Endoscopy, Oct 6, 2005 |