PS-C Femoral Nonporous Rt Sz 6 — Class II medical device recall Z-1610-2014
Terminated recall by Ortho Development Corporation, reported 2014-05-21, distributed nationwide. A femoral component containing pegs was found in a box for the pegless version.
| Recall number | Z-1610-2014 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ortho Development Corporation, Draper, UT, United States |
| Recall initiated | 2014-04-01 |
| Classified | 2014-05-12 |
| Reported by FDA | 2014-05-21 |
| Terminated | 2014-07-14 |
| Distributed | Nationwide (US) |
| Quantity | 5 |
| Lot numbers | A131876 |
| Model numbers | 161-1604 |
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 for recall
A femoral component containing pegs was found in a box for the pegless version.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1610-2014. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.