FDA-Device2014-02-12Class II
***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
Exactech, Inc.
Hazard
Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.
Sold states
USA Distribution including the states of : FL, VA, NY, OH, ME, TX, CO, and GA.
Affected count
235
Manufactured in
2320 NW 66th Ct, Gainesville, FL, United States
Products
***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip Acetabular Augments are indicated for use in skeletally mature individuals undergoing primary or revision surgery for hip replacement and whose orthopedic surgeon desires a prosthetic alternative to structural allograft in cases of segmental acetabular deficiencies.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0906-2014Don't want to check this manually?
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