Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,589 recalls
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Class I - Dangerous
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Lead impedance values reported by the affected VNS generator will be higher compared to those reported by previous models. This is due to a change in the timing of when affected VNS generator takes the lead impedance measurement during diagnostic testing. As a result, normal impedance ranges for the affected VNS generator have shifted relative to the existing thresholds of 600 - 5300 Ohms defined in labeling and as present in the programming software.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Class I - Dangerous
There is a potential for the screws to have become loosened during ultrasonic cleaning of the knobs and the screws may come out.
Class I - Dangerous
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
The instrument holder may be sent on a trajectory that is not within the intended target. If it is not corrected, the associated device may be placed incorrectly.
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Non-highly polished implants may adhere to the LDPE bag (previous packaging configuration).
Implant Direct Scan Adapter Assembly Replant platform for the following part numbers: 6035-09PT-M (3.5mmD)/UDI : 10841307123934,;6043-09PT-M (4.3mmD)/UDI : 10841307123941; and 6050-09PT-M (5.00mmD)/ UDI: 10841307123958
Implant Direct Sybron Manufacturing
Class I - Dangerous
The action is being initiated due to incorrect assembly of the scan adapter . The result of the incorrect assembly could cause the clinician not to be able to capture the position and orientation of a dental implant(s) or lab analog during the digital scanning process which could result in a delay for the patient.
Class I - Dangerous
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Class I - Dangerous
Binding can occur between the attachment bolt and intramedullary nail, which may lead to delays in surgical procedures.
Potential for the wire to fracture at the threads and remain in the glenoid.
OMNI Hip System Model, Catalogue, or Order Number(s): HC-00070 Intended for use as the femoral component of a primary or revision total hip replacement.
OMNIlife science
Class I - Dangerous
Stems missing porous coating on the device.
Class I - Dangerous
Interference can occur between the adolescent attachment bolt and the adolescent nail, cause a delay in surgical procedures
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
Possible suture brittleness or breakage along the Envelope seam before the expiration date of the device.
iTotal Hip Replacement System, Model HBS-033-0015-020101, Size 15 Hip-Patient Specific Stem Right
Conformis
Class I - Dangerous
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
iTotal Hip Replacement System, Model HBS-033-0013-020101, Size 13 Hip-Patient Specific Stem Right
Conformis
Class I - Dangerous
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.