medical Class II Updated 2018-08-08

Encore Medical, Lp recalls Instrument trays used to store AltiVate Small Shell Trials (

Recalled Product

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.


Hazard / Issue

A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.

Issued by

FDA

Affected States: AZ, CA, CO, FL, IN, NJ, NY, NV, MI, MN, MO, OH, RI, SC, TN, TX, UT, WA
Lot/Code Info: 804-99-129 Vendor Lot #22747003
View official government recall

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