TraXis Vue Spinal Implant System, Part #2601-090921
- Company
- Abbott Spine
- Recall Initiated
- November 2, 2005
- Posted
- February 7, 2006
- Terminated
- September 25, 2007
- Recall Number
- Z-0502-06
- Quantity
- 41 units
- Firm Location
- Austin, TX
Reason for Recall
Implants were manufactured without radiographic markers.
Distribution
Nationwide. Implants distributed to Sales Representatives in AZ, CA, FL, GA, KY, IL, MA, NY, OK, PA, TX, UT, VA and WI.
Lot / Code Info
Lot #2010292
Root Cause
Other
Action Taken
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.
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