Recall Z-1258-06 ยท NQO Prosthesis, Spinous Process Spacer/Plate
St. Francis Medical Technologies Inc
St. Francis Medical Technologies brand X STOP Interspinous Process Decompression (IPD) System, 14 mm X STOP implants in peel pouch, Catalog #1-2210; The X STOP consists of a main body, a spacer, and a tissue expander that is secured using a universal wing assembly consisting of a wing and a setscrew. Product is distributed by St. Francis Medical Technologies, Inc., 960 Atlantic Avenue, Suite 102,
| Date | Jul 26, 2006 (initiated Jun 6, 2006) |
| Status | Terminated |
| Reason | Some units may be mislabeled as 10 mm X STOP implant that actually contain 14 mm X STOP implant. |
| Root cause | Other |
| Action | On May 22, 2006, the firm initiated the recall and notification via letters explaining the reason for the recall and requesting the product be returned. |
| Quantity | 4 units |
| Distribution | Worldwide |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.