Class I - Dangerous
Potential breach of sterile barrier due to defective product tray.
ðĶī
Implants & Prosthetics
ðĨ Medical Devices âĒ 4,540 recalls
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.
Total Temporomandibular Joint Replacement System- 45mm Lft 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.
Total Temporomandibular Joint Replacement System- 50mm Lft 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 4, LEFT, REF 71425004, 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
Customed products are being recalled because of compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Class I - Dangerous
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Class I - Dangerous
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
Class I - Dangerous
Internal discovery found that the MRI scans in some PSI knee guides involved an additional rotation adjustments that could potentially lead to misalignment due to a design flaw.
Class I - Dangerous
Significant compromised sterility, not limited to potentially damaged packaging. Serious deficiencies in the manufacturing processes and uncontrolled and inadequate storage conditions increase the risk of contamination and may result in patient infection.
The box of guides for a specific case arrived intact but contained two (2) femoral guides instead of one (1) femoral guide and one (1) tibial guide. The device did not meet specification: One tibia guide missing and one femur guide contained an edge which was +0.04 mm over specification.