Medical DeviceDec 13, 2023
Encore Medical DJO surgical EMPOWR Porous Knee System Empowr 3D Femur-Porous Coated SIZE 8 recall — FDA Z-0508-2024
Due to incorrect product/device within packaging.
Class IIFDA: OngoingEncore Medical, LP
Recall history in this database
Classification mix: Class II: 64.
Medical DeviceNov 15, 2023
Encore Medical DJO EMPOWR Knee Punch Handle, REF: 801-05-040 recall — FDA Z-0258-2024
Knee punch handle tip is breaking during surgery due to the lack of heat treatment, which may lead to a disruption in surgery.
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceNov 15, 2023
Encore Medical RSP Humeral Socket Insert Size 36mm Semi-Constrained +4 mm, REF: 509-01-436 recall — FDA Z-0282-2024
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.
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceNov 15, 2023
Encore Medical RSP Humeral Small Socket Insert Size 32 mm Semi-Constrained +4, e-plus, REF recall — FDA Z-0281-2024
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.
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceOct 18, 2023
Encore Medical REVERSE PROSTHESIS SHOULDER SYSTEM, SCREW, LOCKING BONE, RSP, 5mmX30mm long recall — FDA Z-0098-2024
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.
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceOct 18, 2023
Encore Medical EMPOWR Acetabular System, Liner, 10 Hooded, HXe+, 40H, REF: 942-01-40H recall — FDA Z-0103-2024
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…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceOct 18, 2023
Encore Medical EMPOWR 3D Knee Tibial Insert, 5R, 10MM, VE, REF: 342-10-705 recall — FDA Z-0102-2024
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…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceSep 27, 2023
Encore Medical DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106 recall — FDA Z-2603-2023
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…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceSep 27, 2023
Encore Medical DJO Surgical: Delta Ceramic Femoral Head, 44 mm + 4.0 mm, REF: 400-03-443 recall — FDA Z-2604-2023
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…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceSep 27, 2023
Encore Medical DJO Surgical: CLP Hip, Stem, Polished Neck, Lateral Offset Implant, Size#3 recall — FDA Z-2605-2023
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…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceSep 27, 2023
Encore Medical DJO Surgical: Reverse Shoulder System (RSP) Semi Humeral Socket Insert, 32mm recall — FDA Z-2606-2023
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…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceSep 27, 2023
Encore Medical DJO Surgical: Altivate Reverse, Humeral Stem, Small Shell, Size 6 x 108mm recall — FDA Z-2607-2023
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…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceApr 19, 2023
Encore Medical EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104 recall — FDA Z-1384-2023
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…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceMar 8, 2023
Encore Medical EMPOWR VVC KNEE TIBIAL INSERT, SIZE 6, 22MM, REF: 346-22-706 recall — FDA Z-1187-2023
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…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceNov 2, 2022
Encore Medical EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H recall — FDA Z-0125-2023
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…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceNov 2, 2022
Encore Medical EMPOWER 3D Knee Tibial Insert, REF: 341-14-708 recall — FDA Z-0126-2023
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…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceJun 15, 2022
Encore Medical DJO EMPOWR 3D Knee (Right) 10mm Tibial Insert, REF: 342-10-708 recall — FDA Z-1257-2022
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.
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceSep 1, 2021
Encore Medical AltiVate Anatomic Shoulder System for the following Part Numbers: 1 recall — FDA Z-2331-2021
Complaints have been received concerning the humeral stem failing to mate with the broach handles for a shoulder device. This could result in delay of procedure or revision surgery.
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceJul 28, 2021
Encore Medical DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-12-711, Left Sz. recall — FDA Z-2103-2021
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceJul 28, 2021
Encore Medical DJO Surgical EMPOWR 3D Knee Tibial Insert - e-plus, REF: 341-16-711 Left Sz. recall — FDA Z-2104-2021
Packaging mixup; There is a potential that packaging identified as 12mm knee prosthesis contains 16mm knee prosthesis and 16mm knee prosthesis packaging contains 12 mm knee prosthesis.
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceDec 2, 2020
Encore Medical EMPOWR Partial Knee Peg Drill Guide recall — FDA Z-0479-2021
There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceDec 2, 2020
Encore Medical EMPOWR Partial Knee Peg Drill recall — FDA Z-0480-2021
There have been issues experienced with the peg preparation steps, specifically drilling of the Femoral posterior peg. Upon drilling, the shaft portion of the drill may bind within the…
Class IIFDA: OngoingEncore Medical, LP
Medical DeviceOct 28, 2020
Encore Medical AltiVate Reverse Small Socket Insert, 44mm Semi Constrained - E-Plus, Part recall — FDA Z-0117-2021
Product mislabeled. Use may result in a delay in surgery, stopping of surgery, and revision surgery.
Class IIFDA: TerminatedEncore Medical, LP
Medical DeviceOct 28, 2020
Encore Medical EMPOWR Acetabular System *** EMPOWR Acetabular Cup, Cluster Hole, 54G *** recall — FDA Z-0135-2021
Due to incomplete machining a small peg remnant on the top of the dome that protrudes above the surrounding porous coating causing the cup not to seat properly.
Class IIFDA: OngoingEncore Medical, LP
Understanding this recall history
This page summarizes recall records in which the official source identifies Encore Medical, Lp as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.