Class I - Dangerous
The device is missing grit blasting on the proximal surface of the femoral stem, which may lead to the possibility of product revision in the event of undersizing.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,540 recalls
Class I - Dangerous
There is a potential for distal tip dislodgement or separation.
Class I - Dangerous
There is a potential for distal tip dislodgement or separation.
Class I - Dangerous
There is a potential for distal tip dislodgement or separation.
Torque Limiting Adaptor, AO Connect, 4 N-m, part #027-203, reusable, a component of the Bodycad Fine Osteotomy Implant and Disposable Instrumentation Tray, part #025-004.
Laboratoires Bodycad
Class I - Dangerous
There is a risk of breakage of the torque limiting adaptor if used counterclockwise and it must not be used with a power tool due to no test data validating this use.
GM Helix Acqua Implant 3.5x10, Article No. 140.944
Jjgc Industria E Comercio De Materials Dentarios Sa
Class I - Dangerous
3.5x11.5mm implants were mislabeled as 3.5x10mm implants. In borderline cases where the bone quality is low and the bone ridge has a maximum indication for the implant height (10mm), if the incorrect implant is installed, it could result in damage to the nerve or adjacent bone structures/cavities.
ImplantDirect, REF 834713, Legacy 2 Implant 4.7mmD x 13mmL, 4.5mmD Platform,
Implant Direct Sybron Manufacturing
Class I - Dangerous
Packaged dental implant contains a different size then the size declared on the labeling.
ImplantDirect, REF 834711, Legacy 2 Implant 4.7mmD x 11.5mmL, 4.5mmD Platform,
Implant Direct Sybron Manufacturing
Class I - Dangerous
Packaged dental implant contains a different size then the size declared on the labeling.
Potential for breakage of the ECG electrode carbon stud from the eyelet.
Class I - Dangerous
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Class I - Dangerous
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Heparin, GORE VIABAHN VBX, BALLOON EXPANDABLE ENDOPROTHESIS, REF BXAL085902E, 8 MM X 59 MM 8 Fr, LARGE BALLOON EXPANDLBE, Nominal Stent Diameter 8 mm, Max Post-Dilated Stent Diameter 16 mm, UDI:
W L Gore & Associates
Class I - Dangerous
Incorrect labeling, specifically, expandable endoprosthesis labeled as 8 mm x 59mm x 135 cm, however may contain a 9mm x 29 mm x 135 cm device.
Class I - Dangerous
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Class I - Dangerous
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
Class I - Dangerous
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
Class I - Dangerous
Nonconforming product was distributed in error. Product was nonconforming due endotoxin levels higher than both the Firm's internal endotoxin specification limit and the FDA recommended endotoxin specification limit. Product was released in error based on the results of additional testing performed during the investigation into release testing nonconformance.
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.
Class I - Dangerous
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Some devices are outside tolerances and showed a maximal deviation of 2 degrees in the orientation between the peek head and titanium base, and an incongruence between the size engraved on the peek has been identified. Deviations may delay the final restoration.