FDAFDA · Food and drugs·Recall number Z-0906-2014
***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.
Published February 12, 2014 · Recall initiated: September 11, 2013
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Exactech, Inc.
- Distributor
- USA Distribution including the states of : FL, VA, NY, OH, ME, TX, CO, and GA.
- Lot
- Catalog Numbers: 186-01-08, 186-01-11, 186-01-13, 186-02-08, 186-02-11, 186-02-13, 186-03-11, 186-03-08, 186-03-11, 186-03-13, 186-04-08, 186-04-11, 186-04-13, 186-05-08, 186-05-11, 186-05-13.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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