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All product recalls associated with Conformis Inc..
Total Recalls
13
Past Year
1
Class I (Serious)
0
Most Recent
Mar 2025
Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.
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.
30mm screws were labeled as 25mm screws.
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.
Incorrect tibial base plate implant packaged in kit
Incorrect hip components were provided in kits.
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.
Two femoral stems, sizes 13 and 15, were erroneously switched and packed in each other's packaging.
Incorrect serial number of tibial inserts packaged in tray may result in inserts not fitting
Microscopic cracks potential for pre-mature revisions in patients implanted with the system.