Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
FDA device recall Z-0042-04 · posted 2003-10-15 · Terminated
Recall details
- Recalling firm
- Ortho Development Corporation
- Reason for recall
- The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- JWH
- Quantity affected
- 27
- 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.
- Date initiated
- 2003-09-15
- Date posted
- 2003-10-15
- Date terminated
- 2003-12-11
- Location
- Draper, UT
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