FDA Device

TraXis Vue Spinal Implant System, Part #2601-090921

Hazard

Implants were manufactured without radiographic markers.

What You Should Do

Remedy

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.

Products

TraXis Vue Spinal Implant System, Part #2601-090921
Brand
Abbott Spine
UPC
Lot #2010292

Units Affected

41 units