Drugs & medicalClass II

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.

Read the official notice →
Date
2022-11-02
Country
United States
Brand
Encore Medical
Product
EMPOWR Acetabular System, Liner, 10 deg Hooded, HXe+ 40H, REF: 942-01-40H. Orthopedic implant component.
Classification
Class II
Units
US Nationwide distribution in the states of FL, IN, IL, KY, AZ, TX.
Category
Drugs & medical
Source
FDA · Device

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

  1. Check the product name, strength and lot number against the official notice.
  2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
  3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

More Encore Medical recalls

  1. 2023-10-18
  2. US
    Drugs & medicalClass II

    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 →
  3. US
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    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 →
  4. 2023-09-27
  5. US
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    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 →
  6. 2023-04-19
  7. US
    Drugs & medicalClass II

    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…

    FDA · DeviceEncore Medical, LPUS: TX, IN, MD, CA, KS, AL, HI, WAOfficial notice →
  8. 2023-03-08
  9. US
    Drugs & medicalClass II

    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…

    FDA · DeviceEncore Medical, LPUS: MN, IL, IN, NY, FLOfficial notice →
  10. 2022-06-15
  11. US
    Drugs & medicalClass II

    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 →
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