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…
Read the official notice →- Date
- 2023-04-19
- Country
- United States
- Brand
- Encore Medical
- Product
- EMPOWR Porous Knee Patella Over Drill, REF: 802-05-104; EMPOWR Knee Patella Drill, REF: 802-05-108
- Classification
- Class II
- Units
- US: TX, IN, MD, CA, KS, AL, HI, WA
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2023-10-18
USEncore 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 → - 2023-03-08
- 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 →
Other drugs & medical recalls in the United States
- 2023-04-19
- US
Covidien, LP recalls Step Bladeless Trocars, 10 mm cannula and dilator with radially expandable sleeve and 5 - 10 mm reducer, Product Number S101010
Medtronic was made aware of a supplier calibration issue during the contract sterilization process that may lead to unsterile product. Use of affected product may lead to an unspecified infection or, in the case of…
FDA · DeviceCovidien, LPWorldwide Distribution: US (nationwide) to States of: AR, CA, FL, GA, LA, MA,…Official notice → - US
Howmedica Osteonics Corp. recalls stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 6 RM/LL), REF 170616, intended for use in a Partial Knee Arthroplasty surgical procedure
Certain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
FDA · DeviceHowmedica Osteonics Corp.U.S., Netherlands, Japan, China, India, Korea, and Australia.Official notice → - US
Howmedica Osteonics Corp. recalls stryker MAKO RESTORIS MCK BASEPLATE TRIAL (SIZE 5 RM/LL), REF 170615, intended for use in a Partial Knee Arthroplasty surgical procedure
Ccertain lots of the Restoris MultiCompartmental Knee (MCK) Tibial Baseplate Trials contain product with incorrect size laser marking
FDA · DeviceHowmedica Osteonics Corp.U.S., Netherlands, Japan, China, India, Korea, and Australia.Official notice → - US
Philips North America Llc recalls Philips DigitalDiagnost C50 -intended for use in generating radiographic images of human anatomy Model Number : 712201
If the PM for the telescopic carriage is not performed annually as defined in the Instructions for Use (IFU), the tension force of the spring balancer inside of the telescopic carriage will unavoidably decay through…
FDA · DevicePhilips North America LlcNationwide including Puerto Rico and Virgin Islands Foreign: ARGENTINA…Official notice → - US
Angiodynamics, Inc. recalls NanoKnife 5-Probe Procedure Pack 15 cm - Activation. Indicated for the surgical ablation of soft tissue. Catalog Number: 20400111 UPN:…
Not programmed in accordance with specification. The programming affects the RFID function and does not allow the NanoKnife probes to be recognized by the NanoKnife generator resulting in a delay in procedure
- US
Edwards Lifesciences, LLC recalls Edward Lifesciences, REF 774F75, Swan-Ganz CCOmbo V, CCO/SvO2/CEDV/VIP, Thermodilution Catheter, Exterior Diameter 7.5F (2.5mm), Usable…
There is a potential that the distal end of the catheter may be bent beyond its intended curvature and when connected to patient monitoring device, the monitor may display an error message.
FDA · DeviceEdwards Lifesciences, LLCUS: AK AL AR AZ CA CO CT DC DE FL GA HI IA ID IL IN KS KY LA MA MD ME MI MN MO…Official notice →