ðĨ Medical Devices âĒ 4,589 recalls
Resource Optimization & Innovation
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Resource Optimization & Innovation
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Resource Optimization & Innovation
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
Medtronic Inc. Cardiac Rhythm Disease Management
Some Medical Device Identification Cards provided to SureScan pacemaker patients indicate they have a complete Magnetic Resonance (MR) Conditional system, when in fact, not all of their implanted leads have been FDA approved as MR Conditional.
Resource Optimization & Innovation
The kits contain an equipment glove component which may contain splits or holes compromising the sterility.
MicroPort Orthopedics
Unexpected rate of postoperative fractures resulting in the need for revision surgery.
Stryker Howmedica Osteonics
it was discovered that item 623-10-36I Lot 3Y0KHP, although meeting all device specifications, was determined to be unacceptable due to a documentation issue. However the parts were inadvertently shipped to the field.
The sterile packaging may contain small (less than 250 microns wide) channels in the seal of the pouch. If channels are present, the package integrity is compromised and there is a remote chance that a non-sterile drape may be used during a surgical procedure.
St Jude Medical Cardiac Rhythm Management Division
Some devices exhibit backup VVI operation due to a backup reset.
MUCC2, non-hexed, castable abutment cylinders, has been labeled and distributed as a MUCC1C, hexed, castable abutment cylinders for this one lot only.
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
The firm observed that the BIRMINGHAM HIP(TM) Resurfacing (BHR) System had revision rates which were higher than established benchmarks.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.
Limacorporate S.p.A
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
These screws have a potential of passing through the plate in the case when torque is applied in excessive amounts, which may result in intraoperative malfunction.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.
The device was assembled without screw hole plugs.
Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile.