Aesculap Implant Systems LLC recalls Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code…
Packaging seal integrity not validated resulting in a lack of sterility assurance.
Read the official notice →- Date
- 2022-07-27
- Country
- United States
- Brand
- Aesculap Implant Systems
- Product
- Aesculap Sterile disposable fleece drape, Product code: GA414, individually packaged, 50 pieces per shipping unit, product code SZ380R.
- Classification
- Class II
- Units
- United States: CA, CO, GA, IL, IN, KY, MI, NC, NE, NY, OH, RI, VA and WI
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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 Aesculap Implant Systems recalls
- 2022-09-07
USAesculap Implant Systems LLC recalls Aesculap ENNOVATE SET SCREW STERILE-implants are used for dorsal monosegmental and multisegmental stabilization of the lumbar,…
Potential for the incorrect screw to be included in the package.
- 2022-08-17
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Aesculap Implant Systems LLC recalls Aeos¿ Robotic Digital Microscope with software versions 2.7 or earlier Article Number: PV010
Application error problems: Rebalance scope message: 1.Rebalancing process 2.Usage of Robot Recovery: 3. Autofocus not available:
FDA · DeviceAesculap Implant Systems LLCUS Distribution to states of: AR, IN, NE and NCOfficial notice → - 2022-08-10
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Aesculap Implant Systems LLC recalls PRESTIGE RETRACTION GRASPER, W/PORT DUAL ACTION, ROTATING 5mm DIAM., 36cm LENGTH. Product Code 8361-10
Endoscopic graspers may become separated at the weld from handle to the shaft of the device.
FDA · DeviceAesculap Implant Systems LLCUnited States Nationwide distribution in the states of AK, AL, AR, AZ, CA, CO,…Official notice → - 2022-07-27
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Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
FDA · DeviceAesculap Implant Systems LLCUnited States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC,…Official notice → - US
Aesculap Implant Systems LLC recalls ENNOVATE MIS REMOVALKEY SHORT, product code SZ380R
Fracture or breakage of the spinal fixation arm at the downtube instrument if the 90 degree angle is not met when using the removal key with the spinal fixation system.
FDA · DeviceAesculap Implant Systems LLCUnited States Nationwide distribution in the states of CA, CO, IL, MI, OH & TX.Official notice → - US
Aesculap Implant Systems LLC recalls MODULIFT VBR SZ.M 4MM SET SCREW DRIVER, MF790R, part of Modulift VBR Medium Instrument Set, ST-0441
Set screwdriver fails during surgery by deforming at the tip during engagement and manipulation of the implant.
Other drugs & medical recalls in the United States
- 2022-08-03
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- 2022-07-27
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Stryker Instruments Div. of Stryker Corporation recalls SurgiCount+ System Application, Software Version 2.0.17, Catalog Number 0694-002-090. Used for counting,…
When scanning sponges out after a surgical procedure, an error may allow for a duplicate sponge to be counted without the prompt to make a case note and allowing the case to close. The software update will prevent the…
FDA · DeviceStryker Instruments Div. of Stryker CorporationThe products were distributed to the following US states: KS and ME.Official notice → - US
LumiraDx recalls LumiraDx SARS-CoV-2 Antibody (Ab) Liquid Quality Control
Modification to the LumiraDx SARS-CoV-2 Antibody (Ab) test that was made outside the scope of the approved EUA.
FDA · DeviceLumiraDxDomestic: AR, CA, FL, MA, MD, NC, NJ, NV, NY, OK, TN, TX, & WI.Official notice → - US
Aesculap Implant Systems LLC recalls AESCULAP S4 Cervical Cross Connector L24mm, S4C CROSS CONNECTOR FIXED 24MM, product code SWT113T. Used in spinal fusion surgery.
Insufficient clamping force of the cross connectors in the spinal surgical system which may lead to movement of the connectors on the rods and/or microparticle abrasion.
FDA · DeviceAesculap Implant Systems LLCUnited States Nationwide distribution in the states of CA, CO, IL, IN, MI, NC,…Official notice → - US
Becton Dickinson & Company recalls BD Connecta Stopcock Without Extension Tube Catalog No. 394601 (OUS)
May have the potential for leakage at the housing component of the stopcock, may result in delay or interruption in treatment, exposure to infusate and biohazardous material, under dosing/under infusion, contamination…
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GE Healthcare, LLC recalls SIGNA Premier magnetic resonance scanner, model 5748519.
Under rare conditions, SIGNA Premier gradient coils could result in elevated acoustic noise during scanning. After prolonged periods of elevated acoustic noise, this could potentially lead to hearing loss.
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