FDA Medical Device Recalls (openFDA)
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, unmanageable using other techniques, 5) revision of previously failed total arthoplasty.
- Recall number
- Z-0442-2013
- Recalling firm
- Biomet, Inc.
- 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.
- Status
- Terminated
- Initiated
- 2012-11-06
- Posted
- 2012-11-27
- Terminated
- 2013-08-28
- 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 Friday, 8 a.m. to 5 p.m.
- Quantity
- 4
- Distribution
- Nationwide distribution: USA including states of: AZ, MD, and KS.
- Lot, serial or model codes
- Catalog Number: 192411 and Lot Number Identification: 244800
- 510(k) numbers
- ["K070274"]
- PMA numbers
- not on file
- Product code
- KWA
- Firm FEI
- 1825034
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28