Medical Device
Manufacturing
THE TRADE PAPER OF THE FACTORY FLOOR
Z-0851-03

Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 6mm Lft

Howmedica Osteonics Corp / initiated 2003-01-23 / Terminated

Stryker Howmedica Osteonics began a recall of Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 6mm Lft on . The reason FDA records is "The device is demonstrating early wear and delamination". As of , the recall status on record is Terminated.

Recall record

Recall number
Z-0851-03
Status
Terminated
Initiated
Posted
Terminated
Recalling firm
Howmedica Osteonics Corp
Product
Interax Knee Midi 1 Tibial Inserts. Interax Tib Ins Midi 1 6mm Lft.
Product code
JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall
The device is demonstrating early wear and delamination.
FDA root cause
Other
Action
Recall letters were sent to the Howmedica branches and hospitals on January 23, 2003 via FedEx.
Quantity in commerce
10
Distribution
Howmedica distributed this device to 2 Howmedica branches and 3 hospitals are Parkview Episcopal Hospital, Pueblo, CO; St. Mary Corwin Hospital, Pueblo, CO; and Hement Valley Hospital, Riverside, CA.
Product codes and lots
Catalog No. 66402125  Lot: L7LW; LWWL; LYYX.