Class I - Dangerous
The hip cup liner that was packaged with the incorrect labeling. HDL-060-C22S-000101 from Lot 1788258 contained a hooded liner, but it was labeled to have a standard liner.
ConforMIS
Class I - Dangerous
Size 5 Tibial Tray from Lot 508287 was packaged in a Size 4 box from Lot 540287. It was confirmed that Lot 540287 and Lot 508287 were swapped between the pouching and final pack.
Class I - Dangerous
30mm screws were labeled as 25mm screws.
Class I - Dangerous
Loctite thread locker (epoxy) may not have been applied to the screw that is part of the handle. In the absence of epoxy, the screw may loosen and fall into the patient during a procedure.
Class I - Dangerous
Incorrect tibial base plate implant packaged in kit
Incorrect hip components were provided in kits.
Class I - Dangerous
Outer box labels for kit 0469247 correct, however the boxes contained the implants and jigs for 0468920
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
A limited number of tibial trays were labeled with an incorrect serial number and were delivered to the wrong customer accounts.
Medial and lateral polyethylene inserts did not securely fit into the cobalt chrome tray implant.
Class I - Dangerous
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Class I - Dangerous
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
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.
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 kits were prepared with incorrect patient ID labels and may contain incorrect components.
Class I - Dangerous
The labeling of the boxes and sterile pouches did not match the contents.
Class I - Dangerous
The stage 1 and 2 reamer instruments used to prepare fixation for the cup in the acetabulum had a -1mm interference fit with acetabulum bone. The expected interference fit is -2mm.
Implant kit mislabeled
iView report displayed femoral cut measurements in the incorrect unit of measure (inches vs. mm).
Mislabeled: incorrect serial number on the F4 A/P cut guide iJig.
Class I - Dangerous
Incorrect femoral component distributed
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
May contain small amounts of ethylene glycol residue
Class I - Dangerous
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
Addendum Labeling iTotal CR Surgical Technique with Detailed Instructions of Total CR Poly Insertion Technique