Encore Medical Recalls AltiVate Instrument Trays Due to Coating Issue
Encore Medical is recalling 30 instrument trays used for AltiVate Small Shell Trials because a black coating may appear after cleaning that is not biocompatible.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a non-biocompatible coating that may appear after cleaning, but the source text does not report any illnesses, injuries, or hospitalizations, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Encore Medical, Lp is recalling 30 instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM). These metal containers with lids are used to organize and transport instrumentation for orthopedic surgery and facilitate cleaning and sterilization.
The recall is due to a black, aluminum oxide coating that may appear on the tray after cleaning. The source text states that this black, aluminum oxide coating is not biocompatible.
The affected units were distributed in the United States to the states of AZ, CA, CO, FL, IN, NJ, NY, NV, MI, MN, MO, OH, RI, SC, TN, TX, UT, and WA, as well as to Japan. The specific vendor lot number is 22747003. Users should stop using the affected trays and contact the recalling firm for instructions.
The recalled product
- 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…
- Manufacturer
- Encore Medical, Lp
- Affected units
- 30
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 804-99-129 Vendor Lot #22747003
Distribution
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