FDA-Device2013-08-28Class II
GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
Smith & Nephew Inc
Hazard
The products were produced using the wrong color material, resulting in the devices being red (used for deep dished inserts) instead of blue (used for cruciate retaining inserts).
Sold states
International only: Germany, France, United Arab Emirates, and United Kingdom.
Affected count
9 units
Manufactured in
1450 E. Brooks Rd, N/A, Memphis, TN, United States
Products
GENESIS(R) II CRUCIATE RETAINING ARTICULAR INSERT, TRIAL, SIZE 3-4, A/P 48 MM, M/L 68 MM, QTY 1, NON-STERILE, REF 71430490, Product Usage: Orthopedic
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1996-2013Don't want to check this manually?
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