FDA-Device2012-10-31Class II
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Encore Medical, Lp
Hazard
A product complaint was received where a size 20 screw was labeled as size 30. After receipt, measurement of the screw determined it to be a size 25. Further investigation also determined that there were other screws labeled as size 25, but a size 30 screw was inside of the package. It was thought that all of these screws were found in-house and were contained, but it was determined later that on
Sold states
Nationwide Distribution only to CA.
Affected count
1 unit
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
6.5mm Cancellous Bone Screw Intended to be used for the fixation of the acetabular shell or fracture repair.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0139-2013Don't want to check this manually?
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