🏥 Medical Devices • 4,589 recalls
Encore Medical
The Locking Punch Guide was not sufficiently guiding the large press fit punch, causing the implant to be placed 2-3mm more posterior than intended.
The power drill torque limiter may break during use in surgery application.
Medacta has observed a worldwide occurrence rate of post-operative insert screw back-out of approximately 0.1%. For this reason, we stress the importance of using the 3.5 Nm torque limiting driver if the screw is used, as directed in our surgical techniques.
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
The Spectra System/Legacy Guided Surgery Handle Kit had guided handle inserts that were out of Implant Direct specifications, from the results of complaints submitted by clinicians regarding the 3.4mm guide insert that will not allow the 3.4 drill to pass through, since the diameter is too small. In addition, the 2.3mm guide was too large.
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
Activity and quantity of seeds sent in shipments were incorrect.
When using the downscale option with the Allura R9 system or Azurion R1.1 system, the measurements performed using the QA Basic Measurement tool will not be correctly exported to the external DICOM destination.
The device may contain a manufacturing condition affecting the geometry of the driver's hex feature which prevents it from properly engaging the fixture mount transfer and/or a dental implant.
Possible inner labeling and packaged device not matching the outer label on the box.
Possible inner labeling and packaged device not matching the outer label on the box.
Stent length on the label may not match the length of the stent itself.
One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.
Arthrex part number AR-501-UFLC, size 3, batch 10123297, has the incorrect part number AR-501 ¿UFRA, size 1 printed on the patient label inside the box.
The Legion Screw-on Wedge Size 4 contained 5MM screws instead of the required 10MM screw.
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.
Loss of the seal on the sterile Tyvek packaging used with this Cobalt Bone Cement.