Food, drugs, devices › Ortho Development Corporation
Device recall: Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
FDA enforcement event 85157 is a device recall by Ortho Development Corporation of Draper, UT, initiated 30 May 2019 and classified Class II, with 2 product records.
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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Ongoing. 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
"The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled."
Distribution
"US: CA, FL, OH, PA, TX, and UT. OUS: Japan."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1903-2020 | Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V. | 27 | Class II | Ongoing | 13 May 2020 |
| Z-1904-2020 | Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V. | 29 | Class II | Ongoing | 13 May 2020 |
Context
Other enforcement events for Ortho Development Corporation
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 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 |
| 1 Apr 2014 | PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision S | Device | Class II | 1 |
All 3 events for Ortho Development Corporation
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "The locking mechanism of the tibial tray exhibited a manufacturing defect in which a uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert was being assembled."
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: CA, FL, OH, PA, TX, and UT. OUS: Japan."
Is the recall still ongoing?
FDA lists the status as Ongoing. "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.