U.S. FDA — Device Enforcement · United States · 2011-04-01 · Class II
As described by U.S. FDA — Device Enforcement: 00789502601 VerSys Femoral Head Provisional 26mm -3.5 00789502602 VerSys Femoral Head Provisional 26mm +0 00789502603 VerSys Femoral Head Provisional 26mm +3.5 00789502604 VerSys Femoral Head Provisional 26mm +7 00789502605 VerSys Femoral Head Provisional 26mm +10.5 12/14 Neck Taper The prov
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Terminated — the recall action is complete and the FDA has closed it
Initiated by
Voluntary: Firm initiated
Distribution
Worldwide Distribution - USA (nationwide) and internationally to Canada, Mexico, South America, Europe, Puerto Rico, China, and Korea.
Reported risk: Complaints have been received reporting sub-optimal fit between provisional femoral heads (VerSys and MIS) and the mating components (ie stems and provisional femoral necks), in some cases alleging the fit was too loose and in other cases, alleging the fit was too tight. Intraoperative dislodging of the provisional head and the provisional head being left in-vivo after separating from mating comp
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