Food, drugs, devices › Ortho Development Corporation
Device recall: Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surf
Ortho Development Corporation (Draper, UT) initiated this device recall on 11 Jul 2014; FDA lists 5 product records under event 68898, 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 6 Oct 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
"Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation."
Distribution
"Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees."
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2253-2014 | Pivot Bipolar Cup 22x42/43-51/53mm, REF 133-YYYY Product Usage: Used in a hemiarthroplasty procedure as the bearing surface to articulate with both the CoCr femoral head and the natural acetabulum | 188 | Class II | Terminated | 27 Aug 2014 |
| Z-2254-2014 | Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurface the patella and serve as a bearing surface for sliding contact with the femoral component | 14 | Class II | Terminated | 27 Aug 2014 |
| Z-2255-2014 | PS Tibial Insert, REF 163-1XXX Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component | 11 | Class II | Terminated | 27 Aug 2014 |
| Z-2256-2014 | Tibila Insert UC, Balanced Knee System, REF163-3YYY Product Usage: UHMWPE component used in TKA procedures to serve as a tibial bearing surface for articulation with the femoral component | 13 | Class II | Terminated | 27 Aug 2014 |
| Z-2257-2014 | Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY Product Usage: UHMWPE component used in TKA and revision TKA procedures to serve as a tibial bearing surface for articulation with the femoral component where additional joint constraint is needed | 1 | Class II | Terminated | 27 Aug 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 |
| 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: "Ortho Development is recalling various Pivot Bipolar Cup, Patella, PS Tibial Insert, UC Tibila Insert, and CK Tibil Insert because the foil pouches did not properly seal, allowing air to seep back into the pouch after sealing which increases the risk that the material properties of the implant would be substantially degraded due to oxidation."
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: "Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees."
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 6 Oct 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.