FDA-Device2021-09-01Class II
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
DePuy Orthopaedics, Inc.
Hazard
Package labeled as 16mm x 80mm contained a 16mm x 130mm stem instead and result in obtaining a replacement
Sold states
International distribution in the countries of Canada, France.
Affected count
7 units
Manufactured in
700 Orthopaedic Dr, N/A, Warsaw, IN, United States
Products
ATTUNE REVISION CEMENTED STEM 16X80MM-intended for use in total knee arthroplasty Part Number: 1512-16-080
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2348-2021Don't want to check this manually?
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