OrthoPediatrics Corp recalls Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
Manufacturing variance near transition of tip is increasing the likelihood the wire tip may fracture. The fractured tip may be retained in the patient. Retrieval attempts may be made which could result in a delay of…
Read the official notice →- Date
- 2022-09-14
- Country
- United States
- Brand
- OrthoPediatrics
- Product
- Orthex External Fixation Wire Sharp Bayonet 1.8 x 400 mm Model: K400-18BN
- Classification
- Class II
- Units
- US Nationwide Distribution: AZ, AL, CA, FL, FL, MD, MO, NC, NY, TX Foreign:…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 OrthoPediatrics recalls
- 2023-02-22
USOrthoPediatrics Corp recalls Orthex Large Bone Shoulder Bolt, model no. AS-17
Bolt breakage on the head or threaded portion, which may cause loss of strut continuity with frame. This may cause loss of deformity correction and/or disruption of bone regeneration.
Other drugs & medical recalls in the United States
- 2022-09-14
- US
ICU Medical, Inc. recalls Product Description/Item: ChemoLock Bag Spike, 10 units/CL-10-10; ChemoLock BAG SPIKE w/ ADDITIVE PORT, DRY SPIKE/CL-12; APPX…
Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic…
FDA · DeviceICU Medical, Inc.Worldwide distribution - US Nationwide distribution including in the states of…Official notice → - US
BALT USA, LLC recalls Optima Coil System Model OPTI0520CSF10. For endovascular embolization.
Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.
- US
Abbott Molecular, Inc. recalls Abbott Alinity m SARS-CoV-2 CTRL Kit, REF 09N78-085, each kit contains 12 x 1.3mL CTRL - and 12 x 1.3 mL CTRL +, For In Vitro Diagnostic…
Reports received of an increase of message code 9186 (internal control failed) when using the kit.
FDA · DeviceAbbott Molecular, Inc.Distribution was made to AZ, CA, CT, FL, GA, IL, KS, KY, LA, MA, MI, MN, MO,…Official notice → - US
Biosense Webster, Inc. recalls CARTO VIZIGO 8.5F Bi-Directional Guiding Sheath, REF: D138501. Used to introduce various cardiovascular catheters into the heart.
Outside packaging for a device indicated for introducing cardiovascular catheters into the heart, sustained water damage, which may have affected the sterile barrier of the product inside. Devices with a compromised…
FDA · DeviceBiosense Webster, Inc.US Nationwide distribution in the states of AL, GA, AZ, TX, MA, VA, NY, ME,…Official notice → - US
Ortho-Clinical Diagnostics, Inc. recalls VITROS XT 7600 Integrated System with Version 3.7.2 and below Product Code: 6844461
Performing a system shutdown on VITROS XT 3400 and VITROS XT 7600 Systems may cause a positive or negative shift in the electrical current supplied to the LED used in conjunction with the Digital Imaging Reflectometer.…
FDA · DeviceOrtho-Clinical Diagnostics, Inc.Worldwide distribution - US Nationwide and the countries of Australia,…Official notice → - US