Patella 38mm, REF164-0038 Product Usage: UHMWPE component used in a TKA procedure to resurfa...
FDA Device Recall #Z-2254-2014 — Class II — July 11, 2014
Recall Summary
| Recall Number | Z-2254-2014 |
| Classification | Class II — Moderate risk |
| Date Initiated | July 11, 2014 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Ortho Development Corporation |
| Location | Draper, UT |
| Product Type | Devices |
| Quantity | 14 |
Product Description
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
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 Pattern
Worldwide Distribution - US Nationwide and the country of Japan. No military/govt/VA consignees.
Lot / Code Information
Patella 38mm Part 164-0038, Lot A135844
Other Recalls from Ortho Development Corporation
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-1903-2020 | Class II | Tibial Tray Nonporous A Size 2; Model # PN 162-... | May 30, 2019 |
| Z-1904-2020 | Class II | Tibial Tray Nonporous A Size 4; Model # PN 162-... | May 30, 2019 |
| Z-2256-2014 | Class II | Tibila Insert UC, Balanced Knee System, REF163-... | Jul 11, 2014 |
| Z-2257-2014 | Class II | Tibila Insert CK, Balanced Knee System Revision... | Jul 11, 2014 |
| Z-2255-2014 | Class II | PS Tibial Insert, REF 163-1XXX Product Usage... | Jul 11, 2014 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.