Recall Z-0355-2007
Abbott Spine · initiated November 7, 2006
Product
TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral body replacement system
Codes / lots: Part #2664-1-07 (7mm), 2664-1-09 (9mm), 2664-1-11 (11mm), 2664-1-13 (13mm), 2664-1-15 (15mm).
Reason for recall
Tip of devices may dislodge while in use during surgery.
FDA-determined cause: Other
Action taken
All consignees that have the affected TraXis Fixed Rasps and TraXis Fixed Trials will be contacted via a documented phone script 11/07/2006. Affected inventory will be exchanged for re-worked instruments.
Details
- Recall number
- Z-0355-2007
- Initiated
- November 7, 2006
- Posted by FDA
- January 17, 2007
- Terminated
- October 11, 2007
- Product code
- MQP – Spinal Vertebral Body Replacement Device
- Quantity
- 66 units.
- Distribution
- Worldwide, including USA, Spain, Mexico, United Kingdom, Germany, and Cyprus
- Recalling firm
- Abbott Spine, Austin, TX
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0354-2007 | TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral…Tip of devices may dislodge while in use during surgery. | 11/07/2006Terminated |