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U.S. Department of Health and Human Services

Class 2 Device Recall InteGrip Acetabular Augment

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  Class 2 Device Recall InteGrip Acetabular Augment see related information
Date Initiated by Firm September 11, 2013
Date Posted February 03, 2014
Recall Status1 Terminated 3 on August 04, 2014
Recall Number Z-0906-2014
Recall Event ID 67215
510(K)Number K101761  K113609  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, porous uncemented - Product Code LPH
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.

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.
Recalling Firm/
Manufacturer		 Exactech, Inc.
2320 NW 66th Ct
Gainesville FL 32653-1630
For Additional Information Contact Kaya Davis
352-377-1140
Manufacturer Reason
for Recall		 Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.
FDA Determined
Cause 2		 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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = LPH and Original Applicant = EXACTECH, INC.
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