In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,589 recalls
Total Temporomandibular Joint Replacement System- 45mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Biomet Microfixation
Class I - Dangerous
Laser etching on the parts is wider and deeper than the conditions previously validated.
Total Temporomandibular Joint Replacement System- 50mm Rt Narrow Ti Mand Reconstruction of the temporomandibular joint
Biomet Microfixation
Class I - Dangerous
Laser etching on the parts is wider and deeper than the conditions previously validated.
Total Temporomandibular Joint Replacement System- 50mm Rt Stand Off Ti Mand Reconstruction of the temporomandibular joint
Biomet Microfixation
Class I - Dangerous
Laser etching on the parts is wider and deeper than the conditions previously validated.
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 5, RIGHT, REF 71426005, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Smith & Nephew
Class I - Dangerous
The stem taper on this device is undersized; the gauge point is not deep enough.
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
Report received where the Align Radial Stem fractured.
Total Temporomandibular Joint Replacement System- 45mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
Biomet Microfixation
Class I - Dangerous
Laser etching on the parts is wider and deeper than the conditions previously validated.
Total Temporomandibular Joint Replacement System- 50mm Lft Narrow Ti Mand Reconstruction of the temporomandibular joint
Biomet Microfixation
Class I - Dangerous
Laser etching on the parts is wider and deeper than the conditions previously validated.
Class I - Dangerous
Potential breach of sterile barrier due to defective product tray.
Product shipped to US customers had non U.S. Instruction for use with indication for Use that were not aligned with U.S. indications.
Total Temporomandibular Joint Replacement System- 50mm Lft Standard Ti Mandi Reconstruction of the temporomandibular joint
Biomet Microfixation
Class I - Dangerous
Laser etching on the parts is wider and deeper than the conditions previously validated.
Total Temporomandibular Joint Replacement System- 55mm Lft Standard Ti Mand Reconstruction of the temporomandibular joint
Biomet Microfixation
Class I - Dangerous
Laser etching on the parts is wider and deeper than the conditions previously validated.
Total Temporomandibular Joint Replacement System- 45mm Lft Narrow Ti Mand
Biomet Microfixation
Class I - Dangerous
Laser etching on the parts is wider and deeper than the conditions previously validated.
Total Temporomandibular Joint Replacement System- 45mm Rt Stand Off TI Mand Reconstruction of the temporomandibular joint
Biomet Microfixation
Class I - Dangerous
Laser etching on the parts is wider and deeper than the conditions previously validated.
LEGION(TM) COCR CONSTRAINED FEMORAL COMPONENT, SIZE 6, LEFT, REF 71426006, QTY 1, Smith & Nephew, knee prosthesis Usage:orthopedic.
Smith & Nephew
Class I - Dangerous
The stem taper on this device is undersized; the gauge point is not deep enough.
Class I - Dangerous
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
Total Temporomandibular Joint Replacement System- 55mm Rt Standard Ti Mand Reconstruction of the temporomandibular joint
Biomet Microfixation
Class I - Dangerous
Laser etching on the parts is wider and deeper than the conditions previously validated.
In certain operating room environments, a colored screen image occurs with the 1488 Cameras that were manufactured during a specific time period
Total Temporomandibular Joint Replacement System- 45mm Rt Standard TI Mand Reconstruction of the temporomandibular joint
Biomet Microfixation
Class I - Dangerous
Laser etching on the parts is wider and deeper than the conditions previously validated.