FDA Medical Device Recalls (openFDA)
Ortho Development Corporation: PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
- Recall number
- Z-1610-2014
- Recalling firm
- Ortho Development Corporation
- Product
- PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures.
- Status
- Terminated
- Initiated
- 2014-04-01
- Posted
- 2014-05-13
- Terminated
- 2014-07-14
- Reason
- A femoral component containing pegs was found in a box for the pegless version.
- Root cause
- Process control
- Action
- Ortho notified customers via email and phone calls on April 1, 2014. Customers were asked to return product in inventory.
- Quantity
- 5
- Distribution
- US Nationwide Distribution in the states of NV, and AZ.
- Lot, serial or model codes
- Lot No. A131876
- 510(k) numbers
- ["K994370"]
- 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