Electronic Otto Bock Compact leg prosthesis System, 3C95/3C85, to be used exclusively for the exoprosthetic fitting of a
FDA device recall Z-0363-2007 · posted 2007-01-25 · Terminated
Recall details
- Recalling firm
- Bock,Otto,Orthopedic Ind,Inc
- Reason for recall
- 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.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- KFX
- Quantity affected
- 176
- Distribution
- Nationwide.
- Date initiated
- 2006-08-10
- Date posted
- 2007-01-25
- Date terminated
- 2008-11-26
- Location
- Minneapolis, MN
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| C-LEG (3C100) (K991590) | Otto Bock Orthopedic Industry, Inc. | 1999-07-08 |