Drugs & medicalClass II

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.

Read the official notice →
Date
2023-11-15
Country
United States
Brand
Encore Medical
Product
DJO EMPOWR Knee Punch Handle, REF: 801-05-040
Classification
Class II
Units
US: VA, TN, MN, TX, IL, IN, KY, OH, SC, MS, RI, ME, NJ, NY, MD, CA, KS, LA,…
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 Details may be shortened or out of date; the official notice is the authoritative source.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. 2023-12-20
  2. US
    Drugs & medicalClass II

    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 →
  3. 2023-12-13
  4. US
    Drugs & medicalClass II

    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.

    FDA · DeviceEncore Medical, LPUS Nationwide distribution.Official notice →
  5. 2023-11-15
  6. US
    Drugs & medicalClass II

    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 →
  7. 2023-10-18
  8. 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 →
  9. US
    Drugs & medicalClass II

    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 →
  10. 2023-09-27
  11. US
    Drugs & medicalClass II

    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 →
All 22 Encore Medical recalls →

Other drugs & medical recalls in the United States

  1. 2023-11-15
  2. US
    Drugs & medicalClass II

    Family Dollar Stores, Llc. recalls MEDIC's CHOICE CONTACT LENS SOLUTION 12FLOZ, SKU 998935

    Products were stored outside of labeled temperature requirements.

    FDA · DeviceFamily Dollar Stores, Llc.Distributed to Family Dollar stores in the following states: GA, AL, MS, FL,…Official notice →
  3. US
    Drugs & medicalClass II

    Alcon Research, LLC recalls Alcon Custom-Pak, Surgical Procedure Pack REF 14057-09, 45K W/DUOVISC CATARACT, N VIRGINIA EYE SURG CTR

    Custom surgical procedure packs contain latex gloves but are labeled as "latex free".

    FDA · DeviceAlcon Research, LLCUS: VA OUS: NoneOfficial notice →
  4. US
    Drugs & medicalClass II

    Percussionaire Corporation recalls Monitron II Waveform Analyzer, REF: S00015-1, used with ventilators.

    Note this recall occurred in 2020 and 2021. Reports of screen freeze on visual displays of waveform analyzers that are paired with ventilators. Subsequently, waveform analyzers were serviced to install PAL…

    FDA · DevicePercussionaire CorporationUS: CA, ND, MS, MDOfficial notice →
  5. US
    Drugs & medicalClass II

    Stryker Corporation recalls Disposable Spetzler-Malis Bipolar forceps, 23CM SM DISP BAYONET 1.5MM TIP, Catalog Number 6760-230-015

    An error was identified on the expiration date of the product label. The shelf life for the products impacted is 36 months (3 years) however the product label represents a 54 month (4.5 year) shelf life.

    FDA · DeviceStryker CorporationUS Nationwide. Australia, Canada, Japan, Korea, Singapore.Official notice →
  6. US
    Drugs & medicalClass II

    Edwards Lifesciences, LLC recalls Fogarty Thru-Lumen Embolectomy Catheter, REF: 12TLW805F35

    Inadvertent release of embolectomy catheters that may experience slower than normal balloon deflation (greater-than 15 seconds).

    FDA · DeviceEdwards Lifesciences, LLCOUS: Singapore, Taiwan, CanadaOfficial notice →
  7. US
    Drugs & medicalClass II

    CHANGE HEALTHCARE CANADA COMPANY recalls Change Healthcare Radiology Solutions, software versions 14.0, 14.1, and 14.2 Medical image and information management software.

    Change Healthcare has identified a software issue where Change Healthcare Radiology Solutions 14.0, 14.1, and 14.2 may not update records in external applications.

    FDA · DeviceCHANGE HEALTHCARE CANADA COMPANYUS, Canada, Ireland, Saudi Arabia, France, UKOfficial notice →
See all drugs & medical recalls →