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, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.
FDA Recall Z-0442-2013 · Posted 2012-11-27
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Recalling FirmBiomet, Inc.
Recall StatusTerminated
Product CodeKWA
Date Initiated2012-11-06
Date Terminated2013-08-28
Product Quantity4
Reason for Recall
It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.
Firm 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 Friday, 8 a.m. to 5 p.m.
Root Cause
Labeling Change Control
Distribution Pattern
Nationwide distribution: USA including states of: AZ, MD, and KS.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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