Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Instrument trays used to store AltiVate Small Shell Trials (FA Recalled by Encore Medical, Lp Due to A black, aluminum oxide coating may appear on...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Encore Medical, Lp directly.
Affected 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.
Quantity: 30 units
Why Was This Recalled?
A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
Where Was This Sold?
This product was distributed to 18 states: AZ, CA, CO, FL, IN, MI, MN, MO, NV, NJ, NY, OH, RI, SC, TN, TX, UT, WA
About Encore Medical, Lp
Encore Medical, Lp has 43 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report