Overview of recall records associated with Conformis, Inc., including dates, categories and classifications where available.
Classification mix: Class II: 10.
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.
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.
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.
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.
The kits were prepared with incorrect patient ID labels and may contain incorrect components.
The labeling of the boxes and sterile pouches did not match the contents.
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
This page summarizes recall records in which the official source identifies Conformis, Inc. as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.
