***REF 186-01-08***InteGrip ACETABULAR AUGMENT***SMALL 8mm. Use with 48/50mm Shell.***EXACTECH, Gainesville, FL 32653-16
FDA device recall Z-0906-2014 · posted 2014-02-03 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Exactech is recalling the InteGrip Acetabular Augments due to an out of range condition for an in-vitro biological evaluation standard.
- Action taken
- 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
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 235
- Distribution
- USA Distribution including the states of : FL, VA, NY, OH, ME, TX, CO, and GA.
- Date initiated
- 2013-09-11
- Date posted
- 2014-02-03
- Date terminated
- 2014-08-04
- Location
- Gainesville, FL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NOVATION INTEGRIP ACETABULAR AUGMENTS, GROUPS 4 AND 5 (K113609) | Exactech, Inc. | 2012-01-04 |
| EXACTECH NOVATION EMPIRE ACETABULAR AUGMENT WITH INTEGRIP MODEL 186-01-08/11/13, 186-02-08/11/13, 186-03-08/11/13 (K101761) | Exactech, Inc. | 2010-09-21 |