NuVasive Inc recalls Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2,…
Cervical artificial disc Unique Device Identifier (UDI) barcodes contain the incorrect Global Trade Item Number (GTIN) on the Patient Label when scanned and may also contain the incorrect GTIN human readable text,…
Read the official notice →- Date
- 2022-08-03
- Country
- United States
- Brand
- NuVasive
- Product
- Description/Part: Simplify Disc Size 1, Ht 5/SM-5; Simplify Disc Size 1, Ht 6/SM-6; Simplify Disc Size 2, Ht 4/MD-4; Simplify Disc Size 2,…
- Classification
- Class II
- Units
- US: CA, WA, TX, IN, MO, MI, FL, VA, OR. OUS: DE, NZ, SG, UK
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 recalls
- 2023-02-15
USNuVasive Inc recalls NuVasive MD Pulse III Multimodality System REF 1881500 Pulse Software version 369-BL.US and 369-BLN.US
Due to an incorrect security key, customers were unable to connect to remote monitoring during spinal surgery, neck dissections, thoracic surgeries, and upper and lower extremity procedures.
FDA · DeviceNuVasive IncU.S. Nationwide distribution in the states of CA, FL, NC, OH, and TX.Official notice →- 2022-12-28
- US
NuVasive Inc recalls X-CORE 2 Ti Core, Static. Part of the NuVasive X-Core Expandable VBR System used with spinal fixation.
Potential that insert will be unable to disengage from the vertebral body replacement device/implant
FDA · DeviceNuVasive IncWorldwide - U.S. Nationwide distribution including in the states of NC, CA,…Official notice →
Other drugs & medical recalls in the United States
- 2022-08-03
- US
Paragon 28, Inc. recalls Paragon 28, Inc. System: Baby Gorilla/Gorilla Plating System, Ref: P99-100-2816, Material: Stainless Steel; Desc: Drill, 2.4 X 160mm
Incorrect labeling; There is potential that the drill packaging contains the incorrect part number.
- US
Davol, Inc. recalls X-Stream Irrigation System (Catalog No. 5551000) and X-Stream Irrigation System Refurbished (Catalog No. 9551000)
The device may potentially cause a fire, leading to a safety risk.
FDA · DeviceDavol, Inc.Worldwide distribution - US Nationwide and the countries of Canada and Chile.Official notice → - US
Abbott Laboratories recalls REF: 08P4377, Alinity c Hemoglobin Reagent Kit, IVD, CE, R1 5 x 46.0 mL, R2 5 x 18.3 mL, A1cDL 5 x 67.6 mL
There is a potential for falsely elevated Hemoglobin %A1c and Hemoglobin A1c results to be generated using the ARCHITECT and Alinity c Hemoglobin A1c assay.
FDA · DeviceAbbott LaboratoriesUS: AK AL AR AZ CA CO CT FL GA IA ID IL IN KS KY LA MA MD MI MN MO MS MT NC ND…Official notice → - US
Bard Access Systems, Inc. recalls Intraosseous needle and driver. Catalog/Device Name: D015151NK/BD Needle Kit for Powered Driver 15mm x 15Ga, D015151MK/ BD Manual…
BD Intraosseous Needle Kits may exhibit: 1) Increased force required to remove the stylet from intraosseous needle during placement may cause removal of the entire needle assembly and loss of intraosseous access; 2)…
- US
Integra LifeSciences Corp. recalls CereLink ICP Monitor; Catalog No. 826820, 826820P. Intracranial pressure monitor.
Integra has received complaints associated with ICP readings drifting to -50 mmHg (out-of-range) and may manifest an error message "sensor or extension cable failure!" The firm has found that this is caused by…
FDA · DeviceIntegra LifeSciences Corp.Worldwide Distribution: US nationwide, Australia, New Zealand, Canada, Hong…Official notice → - US
Baxter Healthcare Corporation recalls ABACUS TPN (Total Parenteral Nutrition) Calculation software, Product codes: 8300-0167 (Abacus V3.1 CE), 8300-0168 (Abacus V3.1…
There is a potential risk of medication error when using specific Abacus Order Entry & Calculation software.
FDA · DeviceBaxter Healthcare CorporationUnited States (including Puerto Rico), Argentina, Bermuda, Chile, Colombia,…Official notice →