Every recall we track for Osteomed, LLC — 15 in all — plus the complaints and injury reports the public filed about them.
Osteomed recalls sterile 4mm AutoDrive screws for osteotomies due to potential screwhead undersizing that could pass through plate holes. Affected lots: 1177274, 1177331, 1177823. Contact for return instructions.
Osteomed recalls sterile surgical screws with a potential risk of the screw passing through the plate hole during osteotomies. Affected units include specific lot numbers and model designations.
Osteomed recalls OsteoPower Power Console 2 and 2i models due to electrical safety compliance issues with IEC 60601 standards, which may have caused patient shocks. Affected units include specific model numbers and serial numbers listed in the recall notice.
Osteomed recalls OSTEOVATIONEX 3CC ImpactFormula due to potential loss of setting characteristics within labeled shelf-life. Affected lots include 17102713, 1156491, 17051907, 1136327, 1126984.
Osteomed recalls OSTEOVATIONEX 5CC Impact Formula due to potential shelf-life issues affecting bone void filler setting characteristics. Affected lots: 1128788, 1133246, 1126985, 1135313.
Osteomed recalls OSTEOVATION 3CC ImpactFormula due to incorrect shelf-life labeling. The product may not maintain setting characteristics for the labeled duration, potentially affecting bone healing. Affected units include specific lot numbers listed in the recall.
Osteomed recalls OSTEOVATIONEX 2CC bone void filler kits with potential shelf-life issues. Products may not maintain setting characteristics for labeled duration.
Osteomed recalls OSTEOVATION RMX 10 CC Injectable due to potential shelf-life issues affecting bone void filler setting characteristics.
Osteomed recalls OSTEOVATION 10 CC Impact Formula due to potential loss of setting characteristics after labeled shelf-life. Affected lots include 17051914, 1706050
Osteomed recalls OSTEOVATION 5CC inject formula with incorrect shelf-life; product may not maintain setting characteristics for labeled duration. Affected lots listed.
Osteomed recalls OSTEOVATION 10CC bone void filler kits with incorrect shelf-life. Products may not maintain setting characteristics for labeled duration, risking improper healing.
Osteomed recalls OSTEOVATIONEX 5CC bone void filler kits with incorrect shelf-life. Products may not maintain setting characteristics after the labeled shelf-life.
Osteomed recalls OSTEOVATION RMX 5CC bone void filler kits with incorrect shelf-life. Products may not maintain setting characteristics for labeled duration. Affected lots: 1125793, 1129602, 1132492, 1132347, 1134448, 1137064, 1142080.
Osteomed recalls OSTEOVATION 5CC ImpactFormula due to potential loss of setting characteristics within labeled shelf-life. Affected products have specific lot numbers.
Osteomed recalls OSTEOVATIONEX 3CC bone void filler kits that may not maintain setting characteristics for the labeled shelf-life. Affected kits have specific lot numbers.
