FDAFDA · Food and drugs·Recall number Z-0021-2015
Compress Face Reamer Product Usage: Correction of revision of unsuccessful osteotomy, arthrodesis, or previous joint replacement, tumor resections, revision of previously failed total joint arthroplasty, and trauma.
Published October 15, 2014 · Recall initiated: September 17, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Investigation determined that units supplied were missing the 4x21 degree helix angle.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Biomet, Inc.
- Distributor
- International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.
- Lot
- Catalog numbers: 32-481000 Lot Numbers: 615860, 765230 Catalog Number: 32-481001 Lot Number Identification: 121450, 392410, 765250, 974290
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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