Z-0906-2014 Class II Terminated
FDA device recall Z-0906-2014 was initiated by Exactech, Inc. on Sep 11, 2013 and is designated Class II. Reason for recall: Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard. The recall status is terminated (terminated Aug 4, 2014). Affected quantity: 235.
Recall Details
- Product Type
- Devices
- Report Date
- Feb 12, 2014
- Initiation Date
- Sep 11, 2013
- Termination Date
- Aug 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 235
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.
Reason for Recall
Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.
Distribution Pattern
USA Distribution including the states of : FL, VA, NY, OH, ME, TX, CO, and GA.
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.
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0906-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026