—#114596

Product

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 product code: KWA — Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
Device class: Class 3
Medical specialty: Orthopedic
510(k) numbers: K070274
Affected lot / code info: Catalog Number: 192411 and Lot Number Identification: 244800

Why it was recalled

It was reported that the surgeon noticed that the Echo 11mm hip stem had an etching indicating it was 13mm stem.

Root cause (FDA determination)

Labeling Change Control

Action the firm took

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.

Recalling firm

Firm: Biomet, Inc.
Address: 56 E Bell Dr, Warsaw, Indiana 46582-6989

Distribution

Distribution pattern: Nationwide distribution: USA including states of: AZ, MD, and KS.

Timeline

Recall initiated: 2012-11-06
Posted by FDA: 2012-11-27
Terminated: 2013-08-28
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #114596. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.