TraXis Vue Spinal Implant System, Part #2601-090921
FDA Recall Z-0502-06 · Posted 2006-02-07
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Recalling FirmAbbott Spine
Recall StatusTerminated
Product CodeMQP
Date Initiated2005-11-02
Date Terminated2007-09-25
Product Quantity41 units
Reason for Recall
Implants were manufactured without radiographic markers.
Firm Action
Firm initiated phone contact of all Sales Representatives who received lot and surgeons who have implanted lot on 11/02/05. Recall Letters to be sent to surgeons who have implanted affected lot.
Root Cause
Other
Distribution Pattern
Nationwide. Implants distributed to Sales Representatives in AZ, CA, FL, GA, KY, IL, MA, NY, OK, PA, TX, UT, VA and WI.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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