Assembly, Thigh/knee/shank/ankle/foot, External

LeMaitre Stent Guide: 1102-00 (100 strips); 1102-50 (50 strips); 1102-20 (20 strips).

Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.

Glow 'N Tell 20 cm Tape: 1100-00 (100 strips); 1100-50 (50 strips); 1100-20 (20 strips).

Devices were not sealed correctly during the manufacturing process, and the sterility of these products have been compromised.

Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microproc

A correction of the Otto Bock Compact prosthetic knee joint, material numbers 3C93 and 3C85, is being conducted. A limited number of Compacts have a defective solder connection between the contact wires and battery terminals. If exposed to strong vibrations these Compact knee joints have an increased probability of malfunction and a resultant risk to the Compact wearer.