Encore Medical recalls
22 official recalls and safety alerts involving Encore Medical since 2022-06, from FDA · Device. Newest first. Check the official notice for exact models and batch codes.
This list only includes recalls Recall Atlas has collected since 2021-10. A product not listed here may still be affected; check with Encore Medical or the relevant agency.
- 2026-07-15
USEncore Medical, LP recalls Brand Name: EMPOWR 3D KNEE Product Name: EMPOWR 3D KNEE INS, 11L 14MM, VE Model/Catalog Number: 342-19-703 Product Description: Enovis…
Due to packaging discrepancy with incorrect product size mixed up.
FDA · DeviceEncore Medical, LPGL112 Certus Medical LLC Indiana (IN) & Michigan (MI) 342-19-703 177T1057…Official notice →- 2026-03-04
- US
Encore Medical, LP recalls Brand Name: Reverse Shoulder Prosthesis (RSP) Product Name: RSP HUMERAL SOCKET INSERT, 32MM +4MM, STANDARD HXe-plus Model/Catalog Number:…
Knee and Humeral socket implants contain incorrect labeling.
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of VA, TN, IL, IN, MI, CO, WY, MT,…Official notice → - 2026-02-11
- US
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert 5R 14MM, VE, REF: 342-14-705
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…
FDA · DeviceEncore Medical, LPUS: TX, IA, MI, MS, MA, RI, NJ, PA, NY, MO, OK, PR, AL, CAOfficial notice → - 2025-09-17
- US
Encore Medical, LP recalls Brand Name: DJO SURGICAL Product Name: ALTIVATE REVERSE WEDGE GLENOID REAMER BOSS DRILL, 6.5mm Model/Catalog Number: 804-06-312 Product…
Their is a potential that the reamer may kick or bind up during or immediately prior to use.
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of AL, AZ, CA, CO, FL, HI, IA, IL,…Official notice → - 2025-08-20
- US
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEE INS, 4L 16MM, VE Model/Catalog Number: 341-16-704 Product…
Knee implants contain incorrect labeling (size and/or side incorrect)
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of AL, AZ, CA, CO, FL, IA, IL, IN,…Official notice → - 2025-07-30
- US
Encore Medical, LP recalls Brand Name: EMPOWR Dual Mobility" Product Name: EMPOWR Acetabular, Dual Mobility, Poly Bearing, ID28, OD40 Model/Catalog Number:…
Due to packaging discrepancy with the incorrect tibial inserts/implants being packaged. Issued discovered via a customer complaint.
FDA · DeviceEncore Medical, LPRFK Medical Inc. Viriginia (VA) CE102 952-28-40E 2224A1124A EMPOWR Acetabular,…Official notice → - 2025-07-23
- US
Encore Medical, LP recalls Brand Name: EMPOWR 3D KNEE TIBIAL INSERT - E-PLUS Product Name: EMPOWR 3D KNEETM INS, 11L 12MM, VE Model/Catalog Number: 341-12-711…
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.
FDA · DeviceEncore Medical, LPU.S Distribution to states of: AZ, IA, ID, IL, IN, LA, MI, MO, MS, NE, NY, OK,…Official notice → - 2025-07-02
- US
Encore Medical, LP recalls Brand Name: ALTIVATE REVERSE Product Name: ALTIVATE REVERSE TORX PERIPHERAL SCREW, 26mm Model/Catalog Number: 506-04-126 Software Version:…
Package labeling for Altivate Reverse Torx Peripheral screw contains a different size then actual included product.
FDA · DeviceEncore Medical, LPAt time of quarantine: RFK Medical Inc. Virginia (VA) CE102 506-04-122…Official notice → - 2025-01-01
- US
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert, 5R 16MM, VE, REF: 342-16-705; EMPOWR 3D Knee Tibial Insert, 3R 14MM, VE, REF: 342-14-703
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.
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of VA, MN, TX, WI, IA, IL, IN, SC,…Official notice → - US
Encore Medical, LP recalls EMPOWR 3D Knee Tibial Insert, 6R 10MM, VE, REF: 342-10-706
Knee insert package may contain an acetabular system, which may cause surgical delay to get a new product.
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of IN, KS, CA, FL, NY, TX, AL, WA.Official notice → - 2024-01-10
- US
Encore Medical, LP recalls Reverse Shoulder System e+, REF 509-01-032, RSP Humeral Socket Insert, Sz. 32mm, Semi-Constrained, Sterile H2o2, CE 2797
Mislabeling
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of VA, TN, MN, IN, RI, ME, TX, LA,…Official notice → - 2023-12-20
- US
Encore Medical, LP recalls RSP Glenoid Baseplate, 30mm P2 Porous Coated REF 508-32-204. DJO Surgical shoulder device.
Coating hex did not engage with the Straight Mod Hexdriver or with the Hex Head Screw Driver
FDA · DeviceEncore Medical, LPU.S.: AZ, CA, FL, IN, KS, KY, ME, MN, MS, NJ, OH, Puerto Rico, RI, SC, TN, TX,…Official notice → - 2023-12-13
- US
Encore Medical, LP recalls DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 Left 3D MATRIX COATED REF 243-01-108 DJO surgical EMPOWR…
Due to incorrect product/device within packaging.
- 2023-11-15
- US
Encore Medical, LP recalls RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436, orthopedic shoulder implant component.
Two different humeral socket Insert devices were swapped during packaging, which could result in surgeons not having the correct device for surgery, which could cause a delay in surgery.
FDA · DeviceEncore Medical, LPUS: MN, TX, IN, OH, SC, RI, ME, NJ, NY, KS, LA, FL, CAOfficial notice → - US
Encore Medical, LP recalls DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
FDA · DeviceEncore Medical, LPUS: VA, TN, MN, TX, IL, IN, KY, OH, SC, MS, RI, ME, NJ, NY, MD, CA, KS, LA,…Official notice → - 2023-10-18
- US
Encore Medical, LP recalls EMPOWR Acetabular System, Liner, 10¿ Hooded, HXe+, 40H, REF: 942-01-40H
Knee insert and acetabular system parts were swapped within inner pack prior to the product being sealed within the tray, which could result in surgeons not having the correct product for the surgery due to different…
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of FL, CA, IN, HI, LA, MN, AZ, TX,…Official notice → - US
Encore Medical, LP recalls REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long, REF: 506-03-130
Reverse shoulder prosthesis package that should contain 5mmx30 screws could contain incorrect 3.5mmx30 screws. Use of incorrect screws could result in surgical delay and inadequate fixation.
FDA · DeviceEncore Medical, LPUS: FL, IN, WI, IA, MN, KY, NY, AZ, RI, WA, OH, SC, VA, TX. OUS: MXOfficial notice → - 2023-09-27
- US
Encore Medical, LP recalls DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
Orthopedic device components were not subjected to final sterilization before shipment, which if implanted may lead to varying degrees of infection, which may require treatment, prolonged monitoring, and may lead to…
FDA · DeviceEncore Medical, LPUS: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH,…Official notice → - 2023-04-19
- US
Encore Medical, LP recalls EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
Patella drills are marked with incorrect diameter size of 5.6mm, when they should be 5.4mm. Porous patella overdrills are marked with incorrect diameter size of 5.4 mm, when they should be 5.6 mm. If the incorrect…
- 2023-03-08
- US
Encore Medical, LP recalls EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706; EMPOWR VVC KNEE TIBIAL INSERT, SIZE 7, 22MM, REF: 346-22-707; EMPOWR VVC…
Tibial insert implant large boxes were labeled small and the small boxes were labeled large. If the incorrect labeling is identified this could lead to surgical delay and if the surgeon does not recognize the size…
- 2022-11-02
- US
Encore Medical, LP recalls EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Hip liner implant boxes may contain knee inserts and knee insert boxes may contain hip liner implants, which may lead to implants not being available for surgeries, which may cause delays in surgery.
FDA · DeviceEncore Medical, LPUS Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.Official notice → - 2022-06-15
- US
Encore Medical, LP recalls DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708
A right, size 8, knee tibial insert package may include a mispackaged, left ,size 4, knee tibial insert. If implanted, a risk may include leaving debris in the joint space.
FDA · DeviceEncore Medical, LPU.S. Nationwide distribution in the states of TN, MN, IL, IN, SC, MS, CA, KS.Official notice →