Stryker GmbH recalls Smart Toe II Intramedullary Arthrodesis Implant
The nickel-sensitivity statement on the outer carton may be partially covered by a label resulting in the statement showing "Indicated for patients with Nickel sensitivity" instead of "Not Indicated for patients with…
Read the official notice →- Date
- 2022-05-04
- Country
- United States
- Brand
- Stryker
- Product
- Smart Toe II Intramedullary Arthrodesis Implant
- Classification
- Class II
- Units
- Worldwide distribution - US Nationwide and the countries including Australia,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Stryker recalls
- 2023-09-06
US
Stryker Corporation recalls SurgiCount+ Software Application-indicated as an adjunctive technology for augmenting the manual process of counting, displaying and…
Potential for current software to miscount when scanning in multiple sponge-products from the same unique sponge-pack type
- 2023-05-10
US
Stryker Corporation recalls SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X 10FT 3.05M, REF: 0233-050-200
Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which could cause a clinical delay or procedure being converted to open.
FDA · DeviceStryker CorporationWorldwide - US Nationwide distribution including in the states of PA, MS, IL,…Official notice →- 2023-04-12
US
Stryker Corporation recalls Stryker Color Cuff Non-Sterile Disposable Tourniquet Cuff -NS DISP 30X4,1BLA,1PRT QUICK Catalog number: 5921-030-135NS Indicated for use…
Not able to achieve desired pressure and not holding pressure result from two different causes which have been reported to occur during initial set-up of the cuff onto the patient, may lead to operative site blood…
- 2023-03-08
US
Stryker GmbH recalls stryker Hoffmann LRF, Transport Strut, Model Number 4933-0-400; Orthopedic external fixation device intended to keep bone…
Stryker has identified a nonconformance in specific lots of Hoffmann LRF Bone Transport Struts. Specifically, the thread pitch is oversized at the distal end of the threaded rod, and as a result the distal ring…
US
Stryker Corporation recalls Triton Canister Software Catalog Number: GAUS-2. Intended adjunct in the estimation of blood loss.
Triton Canister Software, Insert & Scanning Label may cause the Triton Canister System to output inaccurate blood loss estimates can lead to confusion and could potentially result in either delayed recognition or…
- 2022-03-16
US
Stryker Corporation recalls 1688 Camera Control Unit (CCU), Catalog number:1688010000. Used in general laparoscopy, nasopharyngoscopy, ear endoscopy, sinuscopy, and…
A software defect in the camera control unit (CCU) will cause the image on the monitor to flip upside-down into an incorrect orientation. The potential of harms are conversion to open procedure, additional medical…
FDA · DeviceStryker CorporationWorldwide distribution. US nationwide including Puerto Rico. OUS: BR, AE, NL,…Official notice →
Other drugs & medical recalls in the United States
- 2022-05-04
US
Instrumentation Laboratory recalls ACL TOP 300 CTS/350 CTS/500 CTS/550 CTS/970 CL: Name Part Number 1.ACL TOP 300 CTS 00000280060 2. ACL TOP 300 CTS 00000280060R…
Updated and revised user instructions issued 7/14/22. Potential carryover issue may cause elevated quality control and sample results for heparin, apixaban or rivaroxaban when HemosIL Liquid Anti-Xa reagent is used in…
FDA · DeviceInstrumentation LaboratoryWorldwide distribution - US Nationwide and the countries of Argentina,…Official notice →US
Waters Medical Systems LLC recalls WAVES WCM Kidney Cassette Module
There is a potential for the WCM cassette pump head leaking solution.
FDA · DeviceWaters Medical Systems LLCWCM cassettes have been distributed to one domestic customer with two…Official notice →US
Draegar Medical Systems, Inc. recalls Drager Infinity CentralStation Software versions VG2.1.2 and VG2.1.2 SU12. For patient monitoring with Infinity M300 wireless…
Software issue resulting in temporary loss of central monitoring functionality.
FDA · DeviceDraegar Medical Systems, Inc.Worldwide distribution - US Nationwide distribution in the states of AL, AR,…Official notice →US
Siemens Medical Solutions USA, Inc. recalls Acuson 9vE4 Transducer, Model (240)11289564 CE0129, Rx Only ,
Transducers (component of ultrasound system) may exceed recommended thermal index limits
FDA · DeviceSiemens Medical Solutions USA, Inc.Worldwide distribution - US Nationwide distribution in the states of…Official notice →US
Roche Diabetes Care, Inc. recalls RocheDiabetes Care Platform Software version 2.5.2 material number 08888353001. This is a web application software hosted on a server.…
Potential for patient data mismatch when using browser "back" button to navigate between patients when using the diabetes management software.
FDA · DeviceRoche Diabetes Care, Inc.US Nationwide Distribution: AK, AZ, CA, CO, DC, FL, GA, IL, IN, MN, NC, NJ,…Official notice →US
Carl Zeiss Meditec AG recalls ZEISS miLOOP Lens Fragmentation Device REF 303071-9090-000. Used during cataract surgery.
High friction of the slider can cause the device to stick, or not move as intended.
FDA · DeviceCarl Zeiss Meditec AGU.S.: AL, AR, AZ, CA, CT, FL, GA, IA, IL, KS, LA, MA, MD, MI, MN, MO, MS, MT,…Official notice →