Recall Z-2238-2008 ยท HXX Screwdriver
Stryker Spine
Reflex Revision Screwdriver Inner Shaft is a orthopedic manual surgical instrument that is a nonpowered, hand held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery. Ref Number 48500900;Non Sterile
| Date | Sep 19, 2008 (initiated Jun 5, 2008) |
| Status | Terminated |
| Reason | The Inner Shaft does not extend far enough from the tip of the Revision Screwdriver to fully engage the bone screw. |
| Root cause | Process control |
| Action | URGENT PRODUCT RECALL letters were sent to all branches/agencies who received the product on June 5, 2008. If you have questions, contact Michelle Klein at 201-760-8256. |
| Quantity | 35 |
| Distribution | The product was distributed to 13 Stryker branches/agencies. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.