ðĨ Medical Devices âĒ 4,589 recalls
W L Gore & Associates
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.
Drill bits packaged in kits are missing the AO connect feature and may result in delay of procedure
Due to product not meeting specification for concentricity and failing to meet requirements of dynamic fatigue testing.
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.
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.
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.
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.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
DePuy Orthopaedics
Packaging may include screws that are not intended to be used with the 5mm augments, may cause delay in surgery
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.
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.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
Inserts were packaged in vacuum bags that lacked an additional oxygen barrier layer.
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.
Corin
The packaging system on the devices have potential physical and water damage resulting in damage to the devices, loss of sterility, or contamination of the devices.