Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL 32653
FDA device recall Z-0572-2008 · posted 2008-03-12 · Terminated
Recall details
- Recalling firm
- Exactech, Inc.
- Reason for recall
- Mislabeled: A ten piece lot of 140-32-03, 12/14 BIOLOXforte Alumina Femoral Heads 32mm (1069020 - 1069029), from Ceramtec were incorrectly labeled as 140-28-03 12/14 BIOLOXforte Alumina Femoral Heads, 28mm
- Action taken
- Exactech issued a recall letter, titled Important Product Recall Notice on 10/31/2007 to the Distibutors that received the recalled product. It requested that all device recipients be notified and all product be returned to the firm.
- Root cause
- Process control
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 10
- Distribution
- Distributed to NY, OH and TN.
- Date initiated
- 2007-11-01
- Date posted
- 2008-03-12
- Date terminated
- 2012-05-06
- Location
- Gainesville, FL
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS (K032964) | Exactech, Inc. | 2003-11-13 |