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Product sterility may be compromised.
Two lots of ON-Q C-bloc, Model Number CB005 may contain an incorrect fill port label.
Package sterile barrier may be breached, compromising sterility.
Mis-labeling: Labeled THA53 device packaging may contain ITHA53 devices (The ITHA53 is designed to be used with an internally hexed implant--The THA53 is used with an external hex platform)
Cleaning cycles are being cancelled. Specific issues are: a) Water heater tank is rusting resulting in the in-line 0.2 micron filter prematurely clogging, b) Interface board malfunction resulting in a premature lid opening, and c) Minor fluid leaks within the system (commonly at the 0.2 micron filter attachment points).
Mis-labeing; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy)
A software error causes the wedge accessory calculation to be ignored in the radiotherapy treatment plan.
Screw Head Dissociation: The polyaxial screw head may dissociate from screw shaft during surgery. Also, the polyaxial screw driver is experiencing difficulty (broken/bent driver shafts, difficulty attaching screws to the driver and jamming of the collet.)
Mis-labeling; The instructions for use include a use for which the device is not intended. (Device not approved to capture a bone biopsy)
Incorrect reading: ITC discovered that instruments built or repaired since approximately April 2007 were inadvertently left with the diagnostic mode enabled when shipped to customers.
The instrument will not mate with its stem.
Skin irritation and burns with product usage
Mislabeled: The packaging of the two products was mixed up, resulting in the products being labeled with an incorrect size. If implanted, the product may not fit properly, which could require repeat surgery. The problem could also result in a delay in the procedure.
The instrument's sizing line is in the wrong place.