Lower riskMedical device recall · FDA · Published June 26, 2018
Encore Medical: Instrument trays with non-biocompatible coating recalled
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.
“Encore Medical: Instrument trays with non-biocompatible coating recalled.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/70743-encore-medical-instrument-trays-with-non-biocompatible-coating-recalled. Based on FDA recall #Z-2600-2018 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2600-2018%22&limit=1).
Encore Medical, LP recalled instrument trays used to store AltiVate Small Shell Trials after the FDA announced the recall on June 26, 2018. The hazard is that a non-biocompatible black aluminum oxide coating may appear on the tray after cleaning.
How to tell if you have it
Brand: Encore Medical
Product: Instrument trays used to store AltiVate Small Shell Trials (FA S ALTIVATE RSP HUM TRLS SM)
Description: Metal container with lid
Vendor Lot #: 22747003
The hazard
A black, aluminum oxide coating may appear on the tray after cleaning. The black, aluminum oxide coating is not biocompatible.
Context
GovInfoNow's records show Encore Medical, LP has 43 other recalls on record since May 31, 2017. Other recent recalls of similar products include EMPOWR 3D Knee Ins 11L 14MM VE Product Mix-Up Recall (Feb. 16, 2026), EMPOWR 3D KNEE Implants Have Incorrect Labeling - Recall Notice (Jan. 15, 2026), and Encore Medical EMPOWR Acetabular System Recall: Packaging Discrepancy May Cause Surgical Delays (Jan. 5, 2026). Other recent recalls of similar products include AVID Medical Haylard Basic Biopsy Tray Recall: Sterility Risk (Aug. 10, 2026), LSL Healthcare Wound Closure Tray Model 7554: Non-sterile Alcohol Prep Pads Recall (March 9, 2026), and AVID Medical Halyard Head and Neck Tray Recall: Potential Incomplete Seal Risk (Nov. 14, 2025).
How to tell if you have this one
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.
Brand
Encore Medical
Category
Medical device
Based on the official FDA remedy
What to do — step by step
Check for Black Coating
Inspect trays for a black, aluminum oxide coating after cleaning. If present, stop using the tray.
Where it went and when
Where it was distributed
Distributed in 18 states, and outside the U.S.
Listed by the agency
Not listed
FDA distribution: “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.” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Arizona, California, Colorado, Florida, Indiana, Michigan, Minnesota, Missouri, Nevada, New Jersey, New York, Ohio, Rhode Island, South Carolina, Tennessee, Texas, Utah, Washington.
Recall timeline
FDA terminated this recall 5.2 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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.
Official source: FDA Recall #Z-2600-2018 (June 26, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2600-2018 to see it in context.
Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.