FDA-Device2018-08-08Class II
Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrumentation by end users.
Encore Medical, Lp
Hazard
A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
Sold states
US Distribution to states of; AZ, CA, CO, FL, IN, NJ, NY, NV, MI, MN, MO, OH, RI, SC, TN, TX, UT and WA and country of; Japan.
Affected count
30 units
Manufactured in
9800 Metric Blvd, N/A, Austin, TX, United States
Products
Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). Metal container with lid used to organize and transport instrumentation to be used in orthopedic surgery. Inner trays also used to facilitate cleaning and sterilization of the instrumentation by end users.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2600-2018Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief