Food, drugs, devices › Ortho Development Corporation
Device recall: PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision S
Ortho Development Corporation (Draper, UT) initiated this device recall on 1 Apr 2014; FDA lists 1 product record under event 68029, classified Class II.
FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 91% of the 1,176 device enforcement events initiated in 2014 carry the same class.
Status: Terminated, terminated 14 Jul 2014. Initiation: voluntary: firm initiated. Ortho Development Corporation has 3 enforcement events on this register, with a median of 2 product records per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Ortho Development Corporation, Draper, UT.
Reason for recall
"A femoral component containing pegs was found in a box for the pegless version."
Distribution
"US Nationwide Distribution in the states of NV, and AZ."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| 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 knee arthroplasty procedures. | 5 | Class II | Terminated | 21 May 2014 |
Context
Other enforcement events for Ortho Development Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 30 May 2019 | Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V. | Device | Class II | 2 |
| 11 Jul 2014 | Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surf | Device | Class II | 5 |
All 3 events for Ortho Development Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "A femoral component containing pegs was found in a box for the pegless version."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution in the states of NV, and AZ."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 14 Jul 2014. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.