Recall Z-0559-03 ยท LXH Orthopedic Manual Surgical Instrument
Sulzer Spine-Tech
Spine-Tech Ancillary Discectomy Instrument (Box Curette), Catalog Number 07.00254.001, in Spine-Tech Ancillary Discectomy Instrument Set, Catalog Number 07.00316.001.
| Date | Feb 21, 2003 (initiated Jan 17, 2003) |
| Status | Terminated |
| Reason | With 14 units distributed, there have been 10 complaints of the product having a twisted or broken tip. |
| Root cause | Other |
| Action | The firm sent a letter, dated January 17, 2003, which requested that the consignees return the product. |
| Quantity | 14 instruments |
| Distribution | The instruments to be recalled are at 2 consignees in California and Mississippi. 21 units are with the firm''s sales representatives. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.