Globus Medical, Inc. recalls ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
A calibration error associated with the Flat Panel Fluoroscopy Fixture when used with ExcelsiusGPS for fluoroscopy workflow may lead to inaccurate navigation, which may result in device misplacement.
Read the official notice →- Date
- 2024-01-24
- Country
- United States
- Brand
- Globus Medical
- Product
- ExcelsiusGPS Flat Panel Fluoroscopy Fixture Kit, Part number 6203.2100
- Classification
- Class I
- Units
- Domestic distribution to the following states: CA, CO, MT, SC, 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Globus Medical recalls
- 2025-04-30
USGlobus Medical, Inc. recalls MAGEC 2 Rod, 5.0mm 90mm Standard; Version/Model: MC2-5090S;
Devices for the affected lot were not assembled according to product specifications. The distraction rod outer diameter was assembled with a 5.5mm rod versus the required 5.0mm.
- 2024-02-14
- US
Globus Medical, Inc. recalls ExcelsiusGPS Cannula A, 9mm x 250mm, Cannula used with ball tip probes, Model No. 6143.2844
Devices may not be rendered sterile due to an internal gap that may be present on some devices causing increased difficulty cleaning prior to steam sterilization. There is an increased risk for infection, inflammation,…
FDA · DeviceGlobus Medical, Inc.Worldwide - US Nationwide and the countries of Australia, Austria, Belgium,…Official notice → - US
Globus Medical, Inc. recalls Globus Medical Cranial Drill, 6.00mm - instruments for access, preparation, and placement of cranial devices with the ExcelsiusGPS. Ref:…
Sterile-packed Cranial Drills may not be sterile due to a breach in the packaging and/or may have discoloration near the drill tip.
FDA · DeviceGlobus Medical, Inc.Worldwide - US Nationwide and the countries of Czech Republic, Poland.Official notice →
Other drugs & medical recalls in the United States
- 2024-01-24
- US
Olympus Corporation of the Americas recalls Soltive SuperPulsed Laser System TFL Fiber Stripper, Model Numbers TFL-AFS150, TFL-AFS200, TFL-AFS365, TFL-AFS550, TFL-AFS940
The strippers and cleavers are provided non-sterile and labelled as reusable/autoclavable. Olympus does not have validated cleaning and sterilization instructions. Use of a non-sterile fiber stripper or cleaver on a…
- US
Maquet Cardiovascular, LLC recalls Product REF 4050-100N, DRAIN, EXPRESS BRU W/AC, Blood Recovery Unit
Express chest drains are pre-packaged with sterile water syringes which have bene recalled. If the device is not kept in an upright position, the patient may be exposed to infectious material. Subsequent hazards…
FDA · DeviceMaquet Cardiovascular, LLCWorldwide distribution: US (nationwide) and OUS (Foreign) to countries of:…Official notice → - US
Percussionaire Corporation recalls Distal Phasitron, Part: S20020, for use with Percussionaire VDR-4 control driver (or control unit)
Breathing circuit reservoir bag may be assembled at the wrong attachment point, which will result in less than optimal therapy.
- US
Percussionaire Corporation recalls High Frequency Transport Phasitron Breathing Circuit Kit REF: A50605-D, Rx Only, CE 0123
Due to an assembly error within the breathing circuit, their pressure output of the breathing circuit kit can be affected and have severe impact to the end user
FDA · DevicePercussionaire CorporationUS:AL AR CA CT FL GA IL IN KS LA MI MN MO NC NJ OH OR TN TX UT VA OUS: NoneOfficial notice → - US
ROi CPS LLC recalls regard Operative LAP, Item Number 800943001; surgical convenience kit
Surgical convenience kits were manufactured with a component which was subsequently recalled by Nurse Assist.
- US
The Procter & Gamble Company recalls Secret OUTLAST Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Protecting Powder, Topical spray can 3.8 oz (107 g),…
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
FDA · DrugThe Procter & Gamble CompanyNationwide USA and Puerto Rico, Canada, Guam, Northern Mariana Islands,…Official notice →