Class I - Dangerous
The surgical cassette contained extra-large white grommets making the 3.8 mm and 6.5mm dental burrs wobble within the grommets in the surgical cassette.
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Implants & Prosthetics
🏥 Medical Devices • 4,540 recalls
Class I - Dangerous
The wrong parts were picked for packaging. The connecting Nuts were packed in the packaging labeled with Hinge coupling
Class I - Dangerous
Packaging design is insufficient to prevent potential sterile barrier breach (pin hole) in Tyvek film of pouch. A limited number of previously recalled devices were inadvertently redistributed.
There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.
There is a potential for improper welding of the yellow staple guide to the instrument. Use of a device with an improperly welded staple guide may result in improper staple formation potentially leading to bleeding or anastomotic leak.
Class I - Dangerous
There is a potential for the connection screw of the stem extractor to break.
Class I - Dangerous
Customers may receive the incorrect size implant from what is labeled on the box.
Class I - Dangerous
There is a potential dry blast irregularity on the locking collar screws packaged with the locking collar.
Class I - Dangerous
The UDI label correctly reads IBR12d-13, however, the inner label incorrectly read IBNT12d-13.
This device was mislabeled and is not the correct component for this patient.
Class I - Dangerous
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
Class I - Dangerous
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
Class I - Dangerous
Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
Certain partial knee implant spacer blocks do not fit in the alignment tower instrument or handle.
Wire sets of certain devices were assembled with adhesive on the contact wires, which may impede conductivity and could cause failure
Class I - Dangerous
It was discovered during a surgery that the design of the radius at the base of the pegs of the Anatomic Glenoid Trial (Part Numbers: 804-07-380, 804-07-420, 804-07-460, 804-07-500, and 804-07-540) is much larger on the trails than on the implants
Class I - Dangerous
Certain packages labeled as size 7.5 Extended Offset Reduced Neck length hip implant, actually contained a Size 4 Standard Reduced Neck length taper hip implant.
Broken or missing screws and retaining clips. This may be due to screw tolerance and material strength of the trial.
Class I - Dangerous
During assembly, an SRS Humeral Distal Body implant failed to engage correctly at the point of reduction with a Discovery Elbow System Humeral Condyle. A mismatch between the screw holes in the Humeral Body & Elbow Condyle affects assembly during surgery. If the product has already been implanted, no action is required. The mismatch is estimated to prevent screw engagement in less than 1% of cases.
Class I - Dangerous
One lot of humeral stem implants do not include the humeral bushing components.