***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL recall
***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation…
Why was ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL recalled?
Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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.
- Product
- ***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-1630. The Exactech Novation…
- Recalling firm
- Exactech, Inc.
- Quantity
- 235
- Distribution
- USA Distribution including the states of : FL, VA, NY, OH, ME, TX, CO, and GA.
- Recall date
- February 12, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)