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Terminated

TraXis Fixed Rasp in sizes: 7mm, 9mm, 11mm, 13mm and 15mm; for use with TraXis vertebral body replacement system

FDA Recall Z-0355-2007 · Posted 2007-01-17

Recalling FirmAbbott Spine
Recall StatusTerminated
Product CodeMQP
Date Initiated2006-11-07
Date Terminated2007-10-11
Product Quantity66 units.

Reason for Recall

Tip of devices may dislodge while in use during surgery.

Firm Action

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

Distribution Pattern

Worldwide, including USA, Spain, Mexico, United Kingdom, Germany, and Cyprus

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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