TraXis Fixed Trial in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; part of TraXis vertebral body replacement system
FDA device recall Z-0354-2007 · posted 2007-01-17 · Terminated
Recall details
- Recalling firm
- Abbott Spine
- Reason for recall
- Tip of devices may dislodge while in use during surgery.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MQP
- Quantity affected
- 76 units.
- Distribution
- Worldwide, including USA, Spain, Mexico, United Kingdom, Germany, and Cyprus
- Date initiated
- 2006-11-07
- Date posted
- 2007-01-17
- Date terminated
- 2007-10-11
- Location
- Austin, TX
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