Paragon 28, Inc. recalls Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
Fibula nail system intended for use in fixation of fibular fractures and osteotomies, has out of specification thread depths on the fibula nail, so implant may not be able to mate properly with the associated mounting…
Read the official notice →- Date
- 2025-12-10
- Country
- United States
- Brand
- Paragon
- Product
- Phantom Fibula Nail, 2.8mm x 130mm, Right, Ti, Fibula Nail, REF: P36-128-130R-S
- Classification
- Class II
- Units
- US Nationwide distribution in the states of NJ, WA, NY, MD, CA, FL, NM, TX,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Paragon recalls
- 2026-08-26
USParagon 28, Inc. recalls Custom Made Device Implant 6123 Navicular Cage Small Right Rev A, Model/Catalog Number 6123S R; foot implant
Device was recalled due to an elevated oxygen level in excess of the allowable limit. Elevated oxygen levels may contribute to reduced material ductility.
- 2026-07-29
- US
Paragon 28, Inc. recalls P28 PHANTON INTRAMEDULLARY NAIL SYSTEM, Phantom Hindfoot TTC/TC Ball Tipped Guide Rod, SIZE: 0.30 mm, LENGTH: 800 mmm, ITem number…
Paragon 28 received two (2) complaints were received involving breaches in the sterile barrier of the pouch packaging.
FDA · DeviceParagon 28, Inc.US nationwide, Australia, Canada, The Netherlands, and New ZealandOfficial notice → - 2024-03-13
- US
Paragon 28, Inc. recalls Phantom TTC Nail, TTC Nail, 11.5 X 250mm, RIGHT, REF: P31-615-250R
Medical devices distributed, prior to sterilization
- 2022-09-28
- US
Paragon 28, Inc. recalls Grappler Suture Anchor, Titanium, 3.0 x 10mm, Sterile Kit, REF: P44-110-3010-SK, for use within the Grappler Suture Anchor System
Suture anchor may break upon insertion, which could lead to potential debris in patient, and delays in surgery.
FDA · DeviceParagon 28, Inc.US Nationwide distribution in the states of AZ, IN, LA, NJ, TX, WA, NY, MD,…Official notice → - 2022-08-03
- US
Paragon 28, Inc. recalls HammerTube Implant, 2.75mm, 10¿ Cannulated (Sterile)
Due to Titanium plasma coating not present implant.
FDA · DeviceParagon 28, Inc.U.S. Nationwide distribution in the states of AL, CA, GA, IL and KY.Official notice → - 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.
Other drugs & medical recalls in the United States
- 2025-12-10
- US
Siemens Medical Solutions USA, Inc recalls MAMMOMAT Inspiration;
There were instances where the operator table was sold together with a bus-installation kit. The operator table is not intended and not released for bus installations as it was designed for stationary operation only.
FDA · DeviceSiemens Medical Solutions USA, IncWorldwide - US Nationwide distribution in the states of AR, CA, NY and the…Official notice → - US
Microbiologics Inc recalls KWIK-STIK, Quality control kit for culture media, Vibrio parahaemolyticus derived from ATCC 17802, Catalog Number 0818K
Some products packaged for lot 818-111-7 may have been packaged in pouches labeled as lot 857-53-10.
FDA · DeviceMicrobiologics IncInternational distribution to the countries of UAE, China, Singapore,…Official notice → - US
Aizu Olympus Co., Ltd. recalls Olympus OER-Elite
Inform existing affected device customers about pertinent Warnings/Cautions, existing recommended maintenance schedules and that only properly trained personnel conduct repairs and maintenance.
- US
Philips North America Llc recalls IntelliVue MP90. Product Number: M8010A.
Potential issue where the IntelliVue monitors did not alarm.
FDA · DevicePhilips North America LlcWorldwide distribution - US Nationwide and the countries of Afghanistan,…Official notice → - US
Fresenius Kabi USA, LLC recalls Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.
Downstream Occlusion alarms may occur during procedures using low flow infusion rates when a check valve* is added to the Ivenix Administration Set.
FDA · DeviceFresenius Kabi USA, LLCUS Nationwide distribution in the sates of CA, CO, FL, GA, ID, IL, MD, MI, MN,…Official notice → - US
Baxter Healthcare Corporation recalls Welch Allyn INF BAG, Thigh 1-Tube, Model/Catalog Number: REF 5089-18; Product replacement bladder for the Welch Allyn Two-Piece…
Replacement bladder kit for the Welch Allyn two-piece reusable blood pressure cuff may contain a Large Adult size bladder rather than a Thigh size bladder in the replacement kits.
FDA · DeviceBaxter Healthcare CorporationUS Nationwide distribution in the states of California, Colorado, Ohio, and…Official notice →