Recall Z-0363-2007 ยท KFX Assembly, Thigh/Knee/Shank/Ankle/Foot, External
Bock,Otto,Orthopedic Ind,Inc
Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of amputations of the lower limb. Microprocessor-controlled prosthetic knee joint used by lower extremity amputees.
| Date | Jan 25, 2007 (initiated Aug 10, 2006) |
| Status | Terminated |
| Reason | 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. |
| Root cause | Other |
| Action | An Urgent Correction Notice, dated August 11, 2006, was sent to customers who purchased the Compact Prosthetic knee joint. The letter identifies affected units, asks for all in stock devices to be returned to Otto Bock, and for patients fitted with an affected device, a loaner knee will be provided as a temporary replacement while their device is serviced. |
| Quantity | 176 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K991590 | C-LEG (3C100) Otto Bock Orthopedic Industry, Inc., Jul 8, 1999 |