The FDA has posted 21 enforcement recalls from Encore Medical, LP since 2025, none of them Class I (most serious). Most recent report: Mar 4, 2026.
Knee and Humeral socket implants contain incorrect labeling.
Knee and Humeral socket implants contain incorrect labeling.
Knee and Humeral socket implants contain incorrect labeling.
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay t…
942-01-40G acetabular system package was found to contain 942-01-36H acetabular system; and several other acetabular system and knee insert devices may also have a packaging discrepancy, which may cause surgical delay t…
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Knee implants contain incorrect labeling (size and/or side incorrect)
Knee implants contain incorrect labeling (size and/or side incorrect)
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Firm name as filed with the FDA: “Encore Medical, LP”. Related firm entities may file under separate names. Source: U.S. FDA openFDA device enforcement reports. Informational only — verify with the FDA before acting.