FDA-Device2023-02-22Class II
EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
MicroPort Orthopedics Inc.
Hazard
One confirmed incident has been received that ETPKN2PL lot 1916559, size 2 Evolution MP Tibial Base, was opened during surgery and contained ETPKN7SL lot 1916715, size 7 Evolution MP Tibial Base, in the packaging.
Sold states
International Distribution to countries of: Germany, Italy, France, Belgium, Austria, Greece, Romania, Japan, and P.R. China.
Affected count
22 units
Manufactured in
5677 Airline Rd, N/A, Arlington, TN, United States
Products
EVOLUTION MP Tibial Bases, Size 7 LEFT, REF ETPKN7SL, knee tibial base
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0276-2023Don't want to check this manually?
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