Z-0906-2014Class II

REF 186-01-08InteGrip ACETABULAR AUGMENTSMALL 8mm. Use with 48/50mm Shell.EXACTECH, Gainesville...

Name: Z-0906-2014 ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville...
Creator: Exactech, Inc.
Published: 2013-09-11
License: https://open.fda.gov/license/

Exactech, Inc. / initiated 2013-09-11 / Terminated / root cause: manufacturing process

FDA source

Exactech, Inc. began a recall of ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation InteGrip... on 2013-09-11. FDA classified it as Class II and gives the reason as "Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0906-2014
Classification: Class II
Status: Terminated
Initiated: 2013-09-11
Posted: 2014-02-03
Terminated: 2014-08-04
Recalling firm: Exactech, Inc.
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.
Product code: LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Reason for recall: Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: Exactech sent an "Important Product Recall Notice" dated September 11, 2013, to all affected customers. The letter identified the product and the action needed to be taken by the customers. Customers were instructed to cease distribution or use of the products. Extend this information to your accounts that may have this product in their possession. Verify if you have any of the subject InteGrip Acetabular Augments (catalog numbers 186-01-08 to 186-05-13) in the specified lots. Complete and fax back the attached form. Further questions, please call 1-800-392-2832.
Quantity in commerce: 235
Distribution: USA Distribution including the states of : FL, VA, NY, OH, ME, TX, CO, and GA.
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0906-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0906-2014	Class II	Terminated	Voluntary: Firm initiated	2014-02-12	2014-02-03

Product code LPH

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)