Aesculap Implant Systems LLC recalls ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic…
Nonfunctional key due to the potential for damage to the key pins cause by force of use during assembly of the tibia locking ring.
Read the official notice →- Date
- 2022-07-27
- Country
- United States
- Brand
- Aesculap Implant Systems
- Product
- ENDURO SPECIAL KEY TIB.LOCK.RING F1/10MM product code NP462R used with EnduRo Total Knee System. instrument used during orthopedic implant…
- Classification
- Class II
- Units
- US Nationwide distribution in the states of AL, AZ, CA, CO, ID, IL, LA, MA,…
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2022-07-27
USAesculap 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.
- US
Aesculap Implant Systems LLC recalls Universal Robot UR5 arm, PV010204 subcomponent of Aesculap Aeos Digital Microscope System, PV010
Malfunction of the robotic arm preventing further movement of the robotic arm and requiring restart of the robotic digital microscope system.
- US
Aesculap Implant Systems LLC recalls RIGHT CORONAL BENDER, TEK1940. Instrument used during spinal surgery.
Customized coronal rod benders may deform the implant when used with the spinal system devices.
- 2022-07-20
- US
Aesculap Implant Systems LLC recalls AESCULAP TC COOELY MICRO NEEDLEHLDER SERR 200MM, product code MG524R. manual surgical instrument designed to grasp a suture needle
Needleholder incorrectly labeled as 200MM when the actual instrument size is 150MM.
- 2021-10-06
- US
Aesculap Implant Systems LLC recalls PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM Catalog Number: FC700SU
Malfuncton-Implant did not deploy successfully may necessitate the need for an additional medical intervention for patients which would result in a potential delay in surgery
FDA · DeviceAesculap Implant Systems LLCUS Nationwide distribution in the states of FL, MI, NY, TX, WI.Official notice →
Other drugs & medical recalls in the United States
- 2022-07-27
- US
Stryker Instruments Div. of Stryker Corporation recalls Triton Sponge System (Software), GAUS-3, Software Versions 4.6.5, 4.8.7, 4.9.6
Gauss Surgical is updating the Instructions for Use (IFU) for our Triton Sponge System in order to clarify proper technique for handling sponges and the calibration placard.
- US
Synapse Biomedical Inc recalls NeuRx Diaphragm Pacing System (NeuRx DPS), Affected part numbers: Part # Part Name 20-0035 NeuRx DPS System Kit 20-0036 NeuRx Diaphragm…
Firm has revised labeling to consistently call out storage conditions and revised the instructions for use to clarify that the temperature range symbol is intended to indicate storage conditions (versus transport…
FDA · DeviceSynapse Biomedical IncDomestic distribution to AL CA CO FL GA IL MA MI MN NC NJ NY OH OK OR PA SC TX…Official notice → - US
Boston Scientific Corporation recalls GreenLight HPSEA Laser Fibers, UPN 0010-2092
Several complaints were received for the affected lot; users received a "Fiber type does not match card type" error message on the GreenLight XPS Laser console, necessitating the replacement of the laser fiber and…
FDA · DeviceBoston Scientific CorporationDomestic distribution to AR CA IL ME MI NC TX Foreign distribution to…Official notice → - US
R & D Systems, Inc. recalls Quantikine IVD Erythropoietin Human Serum Controls for use as quantitative controls for the determination of Erythropoietin concentrations…
The Instructions for Use (IFU, Part Number 750095) provided with the affected lots by the firm contains an error associated with product s CE marking. The CE mark contained in the IFU is followed by the Notified Body…
FDA · DeviceR & D Systems, Inc.Worldwide distribution - US Nationwide distribution in the states of FL, MN,…Official notice → - US
GE Healthcare, LLC recalls GE Healthcare Aisys CS2 Anesthesia System, Part number 1011-9050-000; and Avance CS2 and Avance CS2 Pro Anesthesia System, Part number…
There is a potential reversal of the O2 and air cylinder pressure transducer connections.
FDA · DeviceGE Healthcare, LLCWorldwide Distribution. US nationwide, Australia, Austria, Belgium, Bolivia,…Official notice → - US
Hobbs Medical, Inc. recalls Hobbs Medical Polypectomy Snare, Catalog No. 7202
During use, the sheath of the device may accordion at the proximal end where the sheath meets the shrink band. Kinking of the sheath may prevent the snare from fully closing, and injury may result.
FDA · DeviceHobbs Medical, Inc.Domestic distribution to NC, TX, and WA. Foreign distribution to Canada.Official notice →