Encore Medical, LP

18 FDA enforcement actions

18 Total Recalls

0 Class I

18 Class II

0 Class III

Firm Details

Product Types: device
States: TX

All Recalls

Class II: Risk 01/05/2026 device

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 to exchange devices or revision surgery.
Class II: Risk 01/05/2026 device

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 to exchange devices or revision surgery.
Class II: Risk 07/18/2025 device

Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Class II: Risk 07/18/2025 device

Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Class II: Risk 07/18/2025 device

Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Class II: Risk 07/18/2025 device

Their is a potential that the reamer may kick or bind up during or immediately prior to use.
Class II: Risk 07/09/2025 device

Knee implants contain incorrect labeling
Class II: Risk 07/09/2025 device

Knee implants contain incorrect labeling
Class II: Risk 06/12/2025 device

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Class II: Risk 06/12/2025 device

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
Class II: Risk 06/02/2025 device

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
Class II: Risk 06/02/2025 device

Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. The use of this product may result in the incorrect product being selected. This could result in a revision surgery if used.
Class II: Risk 05/28/2025 device

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Class II: Risk 05/28/2025 device

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Class II: Risk 05/28/2025 device

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Class II: Risk 05/28/2025 device

Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
Class II: Risk 12/18/2024 device

5R 16MM knee tibial insert package may contain knee tibial insert 3R 14MM and vice versa, which may cause surgical delay to get a new product.
Class II: Risk 12/10/2024 device

Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.