Exactech, Inc.: Medical Device Recall in 2014 - (Recall #: Z-0906-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

Product Description:

***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.

Product Classification:

Class II

Date Initiated: September 11, 2013

Date Posted: February 12, 2014

Recall Number: Z-0906-2014

Event ID: 67215

Reason for Recall:

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

Status: Terminated

Product Quantity: 235

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.

Voluntary or Mandated:

Voluntary: Firm initiated