Recall Z-1014-04 ยท HWX Tap, Bone
Zimmer Spine, Inc.
Trinica Bone Tap Instrument, Catalog Number 07.00168.001, sold separately and as part of Zimmer Spine Trinica Anterior Cervical Plating Instrument sets (catalog numbers 07.00215.001 and 07.00546.001). Only the Trinica Bone Tap Instruments are being recalled from the sets.
| Date | Feb 24, 2005 (initiated May 21, 2004) |
| Status | Terminated |
| Reason | The recalled bone taps could break inside the vertebral body during the tapping process. |
| Root cause | Other |
| Action | Recall letters, dated May 25, 2004, request that the consignees locate and return the recalled devices. |
| Quantity | 55 units |
| Distribution | The product was shipped to Hawaii, New York, South Carolina, and South Dakota in the United States. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K022344 | TRINICA SELECT ANTERIOR CERVICAL PLATE SYSTEM Centerpulse Spine-Tech, Inc., Sep 24, 2002 |