Class I - Dangerous
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Limacorporate S.p.A
Class I - Dangerous
There is the potential that the eccentrical adaptor with screw, black laser marking, use to identify the position may be missing.
Class I - Dangerous
Due to a potential difference in mechanical behavior between the implanted device and tool(s) used during revision surgery.
Potential for baseplate peripheral holes to be out of specification due to a manufacturing issue, which could lead to loosening of the implant, or the screw moving from its original position.
Class I - Dangerous
Due to incorrect product labeling
Class I - Dangerous
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Class I - Dangerous
Due to manufacturing issue, their is a potential for peripheral holes to be out of specification.
Class I - Dangerous
Shoulder glenoid fossa prosthesis was manufactured without tantalum markers so in the absence of the markers, on already implanted devices, a correct radiographic assessment of the hybrid glenoid position can be performed by the evaluation of the joint space, central TT peg position and cement mantel observation.
Class I - Dangerous
Due to the incorrect component, that is not cleared to be marketed in the U.S., being included in its elbow prosthesis.
Class I - Dangerous
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Class I - Dangerous
There is a potential that the length of bone screws identified on labeling may not correspond to the actual length of the screw included.
Class I - Dangerous
An internal analysis on complaints received indicated that the welding process may have been performed sub optimally in the 12 lot # involved , leading to reduced mechanical strength of the device and possible breakage during impaction when the instrument is subjected to repeated multi-axial stresses.
Class I - Dangerous
Product found to be dimensionally non-conforming (slightly over dimensioned on the diameter of the Zimmer connection) and non-functional for connecting with some T-handles.
Class I - Dangerous
Complaints of intra-operative breakage of the glenosphere impactors/extractors.
Class I - Dangerous
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.
The dimensions of the mating features of the recalled products are out of specification causing the device to be difficult to assemble.