Recall Z-0466-2007 ยท HTW Bit, Drill
Integra LifeSciences Corp.
BOLD/INI-CLIP 2.2mm Drill Bit with AO Attachment.
| Date | Jan 9, 2007 (initiated Nov 10, 2006) |
| Status | Terminated |
| Reason | Incorrect drill length-Cannulated drill bits were manufactured to incorrect specifications (shorter length) resulting in inadequate preparation of bone prior to insertion of the UNI-CLIP Staple. |
| Root cause | Other |
| Action | An Urgent Recall Notice was sent on 11/10/2006 to both hospitals/distributors and sales representatives by first class mail. |
| Quantity | 107 in US. |
| Distribution | Nationwide to distributors, hospitals and Integra Sales Reps. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K990622 | BOLD SCREW New Deal, S.A., Apr 29, 1999 |