Terminated

REF 186-01-08InteGrip ACETABULAR AUGMENTSMALL 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.

FDA Recall Z-0906-2014 · Posted 2014-02-03

Recalling FirmExactech, Inc.

Recall StatusTerminated

Product CodeLPH

Date Initiated2013-09-11

Date Terminated2014-08-04

Product Quantity235

Reason for Recall

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

Firm 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.

Root Cause

Employee error

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K113609NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5Exactech, Inc. · 2012-01-04 K101761EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13Exactech, Inc. · 2010-09-21

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.