Class I - Dangerous
During manufacture, packaging materials for a small portion of the lot may not have been properly positioned, resulting in a potential breach in sterility.
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Implants & Prosthetics
ðĨ Medical Devices âĒ 4,589 recalls
The safety interlock covering the septum piercing probes within the bulk solution bottle holder may not deploy when a bulk solution bottle is removed from the Alinity ci series and Alinity s System.
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
Class I - Dangerous
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Class I - Dangerous
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110ÂŋF
ULRICH Torque Limiting Handle for use with a Set Screw Driver to perform the final tightening of set screws in a spinal implant construct.
ulrich medical USA
Class I - Dangerous
Certain Torque Limiting Handles in the field are beyond their 3 year calibration life.
Class I - Dangerous
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Class I - Dangerous
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110ÂŋF
Class I - Dangerous
Temperature indicator may have changed color to dark gray or black prior to shipment. Change in color may indicate the product exposure to temperatures greater than 110ÂŋF
Class I - Dangerous
There is the potential for debris/material to be found behind the O-rings in the neck trials.
Class I - Dangerous
Complaints regarding loose proximal body bolts or bolts that were found through x-ray as sitting above the proximal body and not properly seated. Patient risks may include: pain, dissociation, and possible revision surgery
Class I - Dangerous
Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
iTotal Posterior Stabilized (PS) Knee Replacement System, Catalog Number TPS-111-1111 - 020102
Conformis
Class I - Dangerous
The labeling of the boxes and sterile pouches did not match the contents.
Class I - Dangerous
Two lengths of the 6.5mm RingLoc Hip System Self-Tapping Bone Screw may have the potential for the 30mm screws to be packaged as 20mm screws and vice versa.
Class I - Dangerous
Lack of an adequate sterilization validation
Class I - Dangerous
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
Class I - Dangerous
Paltop Surgical Kits contain 1.25mm Hex Driver(s) which may have a slightly oversized hex driving feature, make it difficult to engage screws and abutments containing the corresponding screw feature
The locking plate may be missing from the system, which may result in unexpected stand/table tilt movement that cannot be stopped by the user.
On-X Valve was mislabeled with the incorrect serial number.