CLASS II ONGOING Device recall · Reported 13 May 2020 · FDA Enforcement Report
Tibial Tray Nonporous A Size recalled by Ortho Development
Ortho Development is recalling Tibial Tray Nonporous A Size 4, distributed in California, Florida, Ohio, Pennsylvania, Texas, Utah. The recall was initiated on 30 May 2019 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-1904-2020
- FDA event ID
- 85157
- Recalling firm
- Ortho Development, Draper, UT
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 30 May 2019
- FDA classified
- 5 May 2020
- Reported
- 13 May 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Device Malfunction
- Device type
- Hip & Knee Implants
Timeline
| 30 May 2019 | Recall initiated by company | |
| 5 May 2020 | Classified by FDA | +341 days |
| 13 May 2020 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
Where it was distributed
US: CA, FL, OH, PA, TX, and UT. OUS: Japan.
Questions about this recall
Is Tibial Tray Nonporous A Size 4 recalled?
Yes. Ortho Development recalled Tibial Tray Nonporous A Size 4 on 30 May 2019. The recall is Class II and its status is Ongoing. Recall number Z-1904-2020.
Why was it recalled?
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.
Which lots are affected?
Lot Number: A204324
Where was it sold?
US: CA, FL, OH, PA, TX, and UT. OUS: Japan.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Ortho Development
All 8| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Tibial Tray Nonporous A Size recalled by Ortho Development | Ortho Development | Device Malfunction | 6 states |
| Device | CLASS II | Patella, REF164 recalled by Ortho Development | Ortho Development | Packaging Defects | Nationwide |
| Device | CLASS II | Pivot Bipolar Cup /43 recalled by Ortho Development | Ortho Development | Packaging Defects | Nationwide |
| Device | CLASS II | PS Tibial Insert recalled by Ortho Development | Ortho Development | Packaging Defects | Nationwide |
| Device | CLASS II | Tibila Insert CK, Balanced Knee System Revision, REF563-1YYY recalled | Ortho Development | Packaging Defects | Nationwide |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Nitrosamine Impurity | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Lead & Heavy Metals | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |