TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral body replacement system
- Company
- Abbott Spine
- Recall Initiated
- November 7, 2006
- Posted
- January 17, 2007
- Terminated
- October 11, 2007
- Recall Number
- Z-0355-2007
- Quantity
- 66 units.
- Firm Location
- Austin, TX
Reason for Recall
Tip of devices may dislodge while in use during surgery.
Distribution
Worldwide, including USA, Spain, Mexico, United Kingdom, Germany, and Cyprus
Lot / Code Info
Part #2664-1-07 (7mm), 2664-1-09 (9mm), 2664-1-11 (11mm), 2664-1-13 (13mm), 2664-1-15 (15mm).
Root 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.
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