FDA-Device2014-10-15Class II
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.
Biomet, Inc.
Hazard
Investigation determined that units supplied were missing the 4x21 degree helix angle.
Sold states
International Distribution in the countries of Netherlands, Europe, the Middle East, and Asia.
Affected count
4
Manufactured in
56 E Bell Dr, Warsaw, IN, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0021-2015Don't want to check this manually?
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