DePuy Orthopaedics, Inc. recalls MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000,…
The Cathcart Ball has an inherent +5mm offset which is not currently specified in its Instructions for Use or Surgical Technique Guide. The STG has been updated to reflect the clarification that the +5mm offset should…
Read the official notice →- Date
- 2022-07-20
- Country
- United States
- Brand
- DePuy Orthopaedics
- Product
- MODULAR CATHCART FRACTURE HEAD HIP BALL, sizes 41mm to 60mm inclusive; metallic femoral head prosthesis, Product No. 136341000, 136342000,…
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries of Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 DePuy Orthopaedics recalls
- 2024-04-10
USDePuy Orthopaedics, Inc. recalls ATTUNE AFFIXIUM Cementless Fixed Bearing Knee with 3DP Technology, Size 6. Component of the ATTUNE Total Knee Replacement System.
Product incorrectly labelled.
FDA · DeviceDePuy Orthopaedics, Inc.Worldwide - US Nationwide distribution in the states of CA, IL, NJ, WI and the…Official notice →- 2023-03-29
- US
DePuy Orthopaedics, Inc. recalls Attune Revision Limb Preservation System (LPS) Tibial Insert XXSM 18MM, Part Number 151760118
The subject product lots are being recalled because they received a higher than specified irradiation dose. This exceeds the validated range for exposure to gamma radiation of these devices and may result in changes to…
FDA · DeviceDePuy Orthopaedics, Inc.Worldwide distribution - US Nationwide and the countries of Canada, Poland,…Official notice → - 2022-07-27
- US
DePuy Orthopaedics, Inc. recalls ATTUNE Measured Sizing and Rotation Guide-to size the femur and align rotation of the bone cuts in preparation for the femoral implant…
Manufactured with a Galvanized High Carbon Steel spring instead of the correct 302 Stainless steel spring. has the potential to oxidize and corrode in the ATTUNE Measured Sizing & Rotation Guide, resulting in surgical…
FDA · DeviceDePuy Orthopaedics, Inc.Nationwide Foreign: Argentina, Australia, Austria, Bahrain, Belgium, Brazil,…Official notice → - 2022-05-11
- US
DePuy Orthopaedics, Inc. recalls VELYS Robotic-Assisted Solution Base Product No.: 451570100
System software v1.5.1 has a system software issue related to the Daylight Savings Time (DST) change that can cause a system error, requiring the user to restart the system and potentially cause a delay in treatment
FDA · DeviceDePuy Orthopaedics, Inc.Worldwide distribution - US Nationwide and the countries of Israel, Australia…Official notice → - 2022-02-16
- US
DePuy Orthopaedics, Inc. recalls ATTUNE REVISION POSTERIOR FEMORAL AUGMENT SZ 9 12MM-intended as a Component in total knee arthroplasty (TKA) revision surgeries Product…
May have adhesive residue on the posterior surface of the femoral augment, if undetected prior to implantation, soft tissue irritation and/or infection may occur.
FDA · DeviceDePuy Orthopaedics, Inc.US Nationwide distribution in the states of TN, TX.Official notice → - 2022-01-19
- US
DePuy Orthopaedics, Inc. recalls GLOBAL UNITE REV STEM SZ 10 Product Code: 110010600
Stems may have an undersized spigot bore diameter therefore separating the proximal body from the stem may not be possible without surgical delay and/or bone damage
FDA · DeviceDePuy Orthopaedics, Inc.Worldwide distribution - US Nationwide and the countries of Austria,…Official notice →
Other drugs & medical recalls in the United States
- 2022-07-20
- US
Breas Medical, Inc. recalls Vivo 45LS Ventilator- intended to provide continuous or intermittent ventilatory support for the care of individuals who require…
A forced shutdown of one of the processors did not generate a watch dog alarm, would develop into a failure AND the instructions to monitor a ventilator dependent patient are NOT followed, the health consequences could…
- US
Ivenix, Inc. recalls Ivenix Infusion System (IIS)
Downstream occlusion alarm is sometimes immediately followed by a pump problem alarm.
- US
Waldemar Link GmbH & Co. KG (Mfg Site) recalls Tibial Component Modular. orthopedic prosthesis. Model Nos: Small, W 16-2817/32 Medium, W 16-2817/35 Large, W 16-2817/37
There is a risk that blind screws of the modular tibial component cannot be loosened intraoperatively. This may lead to prolongation of surgery due to an intraoperative change in procedure.
FDA · DeviceWaldemar Link GmbH & Co. KG (Mfg Site)Domestic distribution to AL, CA, FL, GA, IL, IN, KS, MI, MN, NV, NY, OH, TN,…Official notice → - US
Ventana Medical Systems Inc recalls Ventana HE 600 System, automated slide preparer, for use in laboratories.
There is a potential for fluid leak inside the Ventana HE 600 instrument which could result in electrical short and fire
FDA · DeviceVentana Medical Systems IncUS: AL AR AZ CA CO CT DC FL GA HI IA IL IN KS KY MA MD MI MN MO MS MT NC NE NJ…Official notice → - US
Alcon Research, LLC recalls Alcon Custom Pak Surgical Procedure Pack: 16998-11 2519351H SALAHUDDIN 2.4 PACK FRESNO SURGICAL HOSP 18392-03 14HDFF CATARACT SWAGEL…
Due to latex gloves being include in Custom Pak. Kits are supposed to include non-latex gloves.
- US
Siemens Healthcare Diagnostics Inc recalls epoc BGEM Test Card 25 Test Cards/box. In vitro diagnostic device for the quantitative testing of samples of heparinized or…
Discrepant (low bias) pO2 results, could be an incorrect diagnosis of hypoxemia and initiation of unnecessary or inappropriate respiratory support.