Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-1379-04

Modular Knee Joint with Friction Brake

Bock,Otto,Orthopedic Ind,Inc / initiated 2004-07-15 / Terminated

Bock,Otto,Orthopedic Ind,Inc began a recall of Modular Knee Joint with Friction Brake on . The reason FDA records is "Braking Plates of the 3R90 and 3R92 Modular Knee Joint with Friction Brake may become dislodged which may cause the braking performance of the knee to malfunction". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-1379-04
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Bock,Otto,Orthopedic Ind,Inc
Product
Modular Knee Joint with Friction Brake
Product code
ISH Component, External, Limb, Ankle/Foot
Reason for recall
Braking Plates of the 3R90 and 3R92 Modular Knee Joint with Friction Brake may become dislodged which may cause the braking performance of the knee to malfunction.
FDA root cause
Other
Action
The braking plate of the knee may become dislodged, which may cause the braking performance of the knee to malfunction.
Quantity in commerce
457 devices
Product codes and lots
No lot numbers are used. Recall covers patients who were fit with either of the products between March 1, 2004 and July 9, 2004.