Class I - Dangerous
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,540 recalls
Class I - Dangerous
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Class I - Dangerous
Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.
Class I - Dangerous
Electrical failures were identified in cardioverter defibrillators (ICDs) due to damaged aluminum wires. ICDs may contain electrical wire connections which may not be completely insulated. The potential patient impact could be the inability to deliver high voltage therapy. There is no available option to verify the vulnerability status for implanted devices.
Class I - Dangerous
During manufacturing, the screw stop ledge was not made to specification and location within the abutment, resulting in the screw head seating deeper in the abutment with no positive stop.
Certain NAUTILUS DELTA Port Kit product code / lot number combinations may be at risk of experiencing a lack of or a loss of the intravascular ECG signal during port placement procedures when used in combination with the NAUTILUS DELTA" TCS.
Class I - Dangerous
There is a potential for weak seals of the sterile packaging.
Class I - Dangerous
There is a potential for weak seals of the sterile packaging.
Class I - Dangerous
There is a potential for weak seals of the sterile packaging.
Class I - Dangerous
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Class I - Dangerous
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Class I - Dangerous
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Class I - Dangerous
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Class I - Dangerous
Fifteen affected devices were distributed worldwide, which were mislabeled with an incorrect size. In all cases, the actual surgical heart valves are larger than what was indicated on the boxes and jar labels.
Class I - Dangerous
The bearings of the saw attachments were ungreased.
2.7 Degree Straight Sagittal Saw attachment (Mako Total Knee Application and Partial Knee Application 3.0)
Mako Surgical
Class I - Dangerous
The bearings of the saw attachments were ungreased.
Conformis iTotal Hip Replacement System: HBS-033-00xx-010101, (HIP-PATIENT SPECIFIC STEM LEFT)
Conformis
Class I - Dangerous
Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
Conformis iTotal Hip Replacement System: HBS-033-00xx-020101, (HIP-PATIENT SPECIFIC STEM RIGHT)
Conformis
Class I - Dangerous
Discrepancy of 3mm between the values displayed and approved by surgeons in iViews as the neck/head lengths and the resulting neck/head lengths in the manufactured implants.
The OMNIBotics iBlock Cutting Guide does not lock onto the iBlock Saw Guide as intended and may loosen during use.