Class I - Dangerous
Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
TriMed
18 recalls • • Categories: Other Medical Devices, Infusion Pumps, Implants & Prosthetics, Surgical Instruments
Class I - Dangerous
Nail system contains an out of specification driver-socket which could result in inability to pick up nails or apply sufficient torque.
Plates, part of a wrist fixation system, are affixed during surgery with bearings that may pop out from distal peg holes.
Class I - Dangerous
Overly aggressive tension on the pull suture, while passing the medial button through a bone/soft tissue tunnel across the fibula and tibia, can exceed its strength causing it to break.
Class I - Dangerous
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Class I - Dangerous
The spring on the PEG-Extender can rust due to the type of steel used to manufacture it.
Class I - Dangerous
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
Class I - Dangerous
The epoxy on Apex manufactured epoxy-coated instruments can pop off.
The firm has become aware that the angled-hole of certain semi-tubular design bone plates may have been modified from its specification, and the modification may not have been fully qualified.
The WHD/WHV impactors can rust over time due to an improper manufacturing process.
Modifications to the specification were not appropriately qualified through the company's design control process which may result in structural integrity issues of the device.
The bone screw is shorter than the intended design specification.
Two instrument holes located on the side of the plate, which act to align the saw guide are located on the wrong side of the plate
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
Class I - Dangerous
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
Class I - Dangerous
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
Class I - Dangerous
During a retrospective review of sterilization records, TriMed has determined that evidence of quarterly dose audits/verification required to comply with the regulations could not be found. Sterilization records indicate that all lots of staples were irradiated to at least the defined dose. There is a risk that this issue could result in patient infection if not properly sterilized.
Following the completion of sterilization cycle(s) of the impacted Hex Driver, the epoxy color band on the impacted Hex Driver can migrate down the shaft and/or potentially onto the sterilization tray or caddy.
TriMed is recalling the Semi-Tubular Plates with 10 holes (SMTP-10) because a non-locking screw passed through a hole in a SMTP-10 plate being implanted.