Reported May 13, 2020 · Ongoing
Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
Ortho Development Corporation
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Ortho Development Corporation · 12187 S Business Park Dr · Draper, UT · 84020-8663
Is this the product you have?
- Tibial Tray Nonporous A Size 4; Model #
- PN 162-1400-A MaterialTi6Al4V
- Lot codes and dates
- Lot NumberA204324
- Amount recalled
- 29
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was 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.
This product could cause temporary or reversible health problems — stop using it.
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