Encore Medical recalls instrument trays used in orthopedic surgery due to potential non-biocompatible black coating after cleaning. Affected units may pose health risks if used improperly.
A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
Encore Medical is recalling instrument trays used in orthopedic surgery because cleaning can leave a black, non-biocompatible aluminum oxide coating. This coating could cause health issues if the trays are used without proper cleaning.
The black aluminum oxide coating forms after cleaning and is not biocompatible. This means it could cause health problems if the trays are used without being cleaned properly.
Orthopedic surgeons and medical staff who use these trays for surgery instruments. Patients are at risk if the trays are used without proper cleaning.
Look for trays with the model number 'FA S ALTIVATE RSP HUM TRLS SM' or lot number '22747003'. These trays have a metal container with a lid used in orthopedic surgery.
Inspect trays for a black, aluminum oxide coating after cleaning. If present, stop using the tray.
The black aluminum oxide coating is not biocompatible, which means it could cause health issues if the trays are used without proper cleaning.
Check for the black coating after cleaning. If present, stop using the tray immediately.
Look for the model number 'FA S ALTIVATE RSP HUM TRLS SM' or lot number '22747003' on the trays.
We’ve drafted a message you can send Encore Medical to request your refund or repair — edit it as you like.
Subject: Recall Z-2600-2018 — Encore Medical Encore Medical Hello, I own a Encore Medical that is covered by recall Z-2600-2018 from Encore Medical. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
