Recall Z-0442-2013 ยท KWA Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Biomet, Inc.
Echo Bi-Metric Press-Fit Stems/Echo Bi-Metric 11mm x 135mm Collarless Porous Stem (Orthopedic Implant) Indications: 1) Noninflammatory degenerative joint disease including osteoarthritis and avascular necrosis, 2) rheumatoid arthritis, 3) correction offunctional deformity, 4) treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unm
| Date | Nov 27, 2012 (initiated Nov 6, 2012) |
| Status | Terminated |
| Reason | It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem. |
| Root cause | Labeling Change Control |
| Action | The firm, Biomet, sent an "URGENT MEDICAL DEVICE RECALL NOTICE" dated November 8, 2012 to its customers. The notice describes the product, problem and actions to be taken. The customers were instructed to take the following actions: Immediately locate and remove the identified device(s) listed below from circulation. Carefully follow the instructions on the enclosed FAX Back Response Form. Fax a copy of the Response Form to 574-372-1683 prior to return of product. Use priority carrier for your shipment. Questions related to notice should be directed to (574) 372-1570, Monday through Frida |
| Quantity | 4 |
| Distribution | Nationwide distribution: USA including states of: AZ, MD, and KS. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K070274 | ECHO BI-METRIC PRESS-FIT STEMS Biomet Manufacturing Corp, Apr 3, 2007 |