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Recall Observatory FDA recall evidence

Device product

***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.

Z-0906-2014

September 11, 2013

Class II

Product summary

Firm
Exactech, Inc.
Event
Event 67215
Status
Terminated
Classification
Class II
Quantity
235
Official record key
device-enforcement:Z-0906-2014

Official wording

Reason: Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.

Code information: 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.

Distribution pattern: USA Distribution including the states of : FL, VA, NY, OH, ME, TX, CO, and GA.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.