FDA Medical Device Recalls (openFDA)
Ortho Development Corporation: Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
- Recall number
- Z-0042-04
- Recalling firm
- Ortho Development Corporation
- Product
- Guide pin (component of the Tibial Punch Guide) of the Balanced Knee System.
- Status
- Terminated
- Initiated
- 2003-09-15
- Posted
- 2003-10-15
- Terminated
- 2003-12-11
- Reason
- The guide pin which rotationally constrains the tibial punch within the punch guide, may fall out.
- Root cause
- Other
- Action
- 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.
- Quantity
- 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.
- Lot, serial or model codes
- Part # 252-0300, Lot # W007919.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 3017298928
- Firm city
- Draper
- Firm state
- UT
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28