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…
Read the official notice →- Date
- 2023-09-27
- Country
- United States
- Brand
- Encore Medical
- Product
- DJO Surgical: Empowr Knee, Universal Tibia Baseplate, 6R, REF: 352-02-106
- Classification
- Class II
- Units
- US: AL, AZ, CA, CO, FL, IL, IN, KS, KY, LA, MA, MI, MN, MO, NC, NJ, NY, OH,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- 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
- 2023-11-15
USEncore 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 → - 2023-04-19
- 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 →
Other drugs & medical recalls in the United States
- 2023-09-27
- US
Tytek Medical Inc recalls TyTek Tension Pneumothorax Access Kit TPAK 14 gauge 3.25 inch- Intended for introduction into the body to facilitate removal of air from…
Updated IFU to inlclude: (1) identify the risks associated with the hazard of needle decompression and (2) improve the artwork showing placement site location
FDA · DeviceTytek Medical IncOH, SC, VA Foreign: Country Australia Denmark Finland Germany Hong Kong/China…Official notice → - US
Randox Laboratories Ltd. recalls Liquid Assayed Chemistry Control Premium Plus Level 3, Catalog Number LAE4215
there has been a transcription error in the Instructions for Use (IFU) for the Liquid Assayed Chemistry Control Premium Plus Level 3. For Caeruloplasmin, the one and two standard deviation values printed on the sheet…
- US
Philips North America Llc recalls Patient Information Center iX with Software Version Number 4.x in the following: (1) Patient Information Center iX Product Number:…
Patient Information Center (PIC iX) Release 4.x Surveillance Crash Caused by Intel Graphics Driver Error-with a blank screen and subsequently require a manual reboot of the hardware to restart and continue central…
FDA · DevicePhilips North America LlcNationwide Foreign: Austria Bahrain Belgium Canada Czech Republic Denmark…Official notice → - US
Stryker Corporation recalls Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high…
Potential for the Break-Away Femoral Nozzle the applicator tip connecting the cement cartridge, to disassemble or break off during use, can lead to the potential for loss of function of the ACM system and…
FDA · DeviceStryker CorporationNationwide Foreign: Austria Belgium Canada France Germany Hong Kong Italy…Official notice → - US
MEDLINE INDUSTRIES, LP - Northfield recalls MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049
4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large…
FDA · DeviceMEDLINE INDUSTRIES, LP - NorthfieldWorldwide distribution: US (nationwide) and OUS (foreign) countries of:…Official notice → - US
Aquila Corporation recalls APK2 Pressure-Sensing Wheelchair Cushions
Defective battery pack in wheelchair cushions can overheat resulting in property damage and one possible injury.
FDA · DeviceAquila CorporationWorldwide distribution: US (nationwide) and OUS (foreign) countries of:…Official notice →