Recall Z-0572-2008 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Exactech, Inc.
Exactech 12/14 Biolox Alumina Femoral Head 28MM +3.5, hip prosthesis component, Exactech, Gainesville, FL 32653
| Date | Mar 12, 2008 (initiated Nov 1, 2007) |
| Status | Terminated |
| Reason | 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 |
| Root cause | Process control |
| Action | 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. |
| Quantity | 10 |
| Distribution | Distributed to NY, OH and TN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K032964 | EXACTECH 12/14 ALUMINA FEMORAL HEAD; EXACTECH ACUMATCH M-SERIES 12/14 NECK SEGMENTS Exactech, Inc., Nov 13, 2003 |