FDA Device recall Z-1610-2014
PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total kn…
- FDA Device
- Class II
- terminated
- Published 2014-05-21
On 2014-05-21 the FDA classified a Class II recall of PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total kn… by Ortho Development, citing A femoral component containing pegs was found in a box for the pegless version.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1610-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-04-01 |
| Published | 2014-05-21 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Ortho Development |
| Distribution | US |
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.
Reason
A femoral component containing pegs was found in a box for the pegless version.
Identifiers
| code_info | Lot No. A131876 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1610-2014%22
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