Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
This recall has been terminated (originally issued October 15, 2003).
- Company
- Ortho Development Corporation
- Recall Initiated
- September 15, 2003
- Posted
- October 15, 2003
- Terminated
- December 11, 2003
- Recall Number
- Z-0042-04
- Quantity
- 27
- Firm Location
- Draper, UT
- Official Source
- View on FDA website ↗
Reason for Recall
The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.
Distribution
Units were sent to distributors in AZ, CA, FL, MO, OK and TX. Units were also distributed to firm's parent company in Japan.
Lot / Code Info
Part # 252-0300, Lot # W007919.
Root Cause
Other
Action Taken
The firm has telephoned all distributors regarding the recall. An advisory note and product return request letters were sent to all distributors on 9/15/03.
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