NuVasive Specialized Orthopedics, Inc. recalls Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX…
Due to potential issues with design, manufacturing and documentation issues related to the validation of the affected products/devices.
Read the official notice →- Date
- 2024-11-27
- Country
- United States
- Brand
- NuVasive Specialized Orthopedics
- Product
- Precice Max REF: PM10.0-80B265 PRECICE MAX Antegrade Femur Piriformis Straight 10.0mm x 265mm PM10.0-80B280 PRECICE MAX Antegrade Femur…
- Classification
- Class II
- Units
- U.S distribution to states of: FL and NV.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 NuVasive Specialized Orthopedics recalls
- 2022-12-21
USNuVasive Specialized Orthopedics, Inc. recalls NUVASIVE MAGEC MAGEC 2 Rod. The MAGEC System is used to brace the spine during growth to minimize the progression of…
During accelerated shelf-life extension studies it was noted that the final packaging was experiencing a potential of failure of the sterile packaging barrier which could result in a hazardous situation where the…
FDA · DeviceNuVasive Specialized Orthopedics, Inc.Distribution US nationwide including Puerto Rico; Chile, Israel, Jordan, New…Official notice →- 2022-02-02
- US
NuVasive Specialized Orthopedics, Inc. recalls MAGEC 1 System
Safety Alert to all surgeons informing them of post-implantation fractures of an internal metallic component for device manufactured prior to March 26, 2015.
- 2021-12-08
- US
NuVasive Specialized Orthopedics, Inc. recalls NUVASIVE PRECICE Intramedullary Limb Lengthening (IMLL) and (Short) System: Model Number/Item Number/Product Description:…
The Instructions for Use have been updated to include: (1) Clarification that the device is intended for use only in patients 18 years and older, (2) That patients should weigh 50 lbs. or more while undergoing…
FDA · DeviceNuVasive Specialized Orthopedics, Inc.U.S.: AK, AL, AR, AZ, CA, CO, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA,…Official notice →
Other drugs & medical recalls in the United States
- 2024-12-04
- US
- 2024-11-27
- US
Zyno Medical LLC recalls Z-800 Infusion System. Model/Catalog Number: Z-800, Z-800F, Z-800W, Z-800WF. The Z-800 Infusion system is intended to provide intravenous…
Potential for the battery to deplete over time from self-discharge and internal parasitic leakage current despite being continuously plugged into AC mains.
- US
OrganOx Ltd recalls OrganOx metra -Intended as a Normothermic Machine Perfusion system of donor transport livers. Model/Catalog Number: D0003 The OrganOx…
Battery movement led to damage of one of the battery cells causing it to short to the battery retention bracket
FDA · DeviceOrganOx LtdCalifornia, Texas, Ohio, Florida, New York, Massachusetts, Virginia, Oklahoma,…Official notice → - US
Cook Incorporated recalls Approach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Devices from the affected device lots have labels that state the incorrect expiration dates.
- US
Olympus Corporation of the Americas recalls Brand Name: EVIS EXERA III Gastrointestinal Videoscope GIF-1TH190 Product Name: Olympus GIF-1TH190 Model/Catalog Number:…
To better define the drying procedures described in the IFU to improve the instructions for easier understanding of each drying step after human errors and concerns were identified when completing a Human Factors…
FDA · DeviceOlympus Corporation of the AmericasDomestic: US Nationwide Distribution.Official notice → - US
Philips Medical Systems Technologies Ltd. recalls Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to…
A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in…
FDA · DevicePhilips Medical Systems Technologies Ltd.US Nationwide and Worldwide Distribution Foreign: Country Argentina Australia…Official notice →