—#125015

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.

FDA product code: LPH — Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K101761, K113609
Affected lot / code info: 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.

Why it was recalled

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

Root cause (FDA determination)

Employee error

Action the firm took

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.

Recalling firm

Firm: Exactech, Inc.
Address: 2320 NW 66th Ct, Gainesville, Florida 32653-1630

Distribution

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

Timeline

Recall initiated: 2013-09-11
Posted by FDA: 2014-02-03
Terminated: 2014-08-04
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #125015. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.