Ortho Development recalls Tibial Tray Nonporous A Size 4 (Model PN 162-1400-A) due to assembly resistance risk from a manufacturing defect in the locking mechanism.
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.
Ortho Development is recalling Tibial Tray Nonporous A Size 4 models with specific model numbers because a manufacturing defect may cause resistance when assembling the Tibial Insert. This could lead to improper fitting or injury during use.
The locking mechanism has a uniform ridge cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when assembling the Tibial Insert. This resistance could lead to improper fitting or injury during use.
Ortho Development's Tibial Tray Nonporous A Size 4 (Model PN 162-1400-A) is likely used by patients with orthopedic implants. Those with the specific model number are most at risk.
Check for the model number PN 162-1400-A on the Tibial Tray Nonporous A Size 4. The product was manufactured with Lot Number A204324.
Verify the model number is PN 162-1400-A on the Tibial Tray Nonporous A Size 4.
The locking mechanism has a manufacturing defect that may cause resistance when assembling the Tibial Insert, potentially leading to improper fitting or injury.
The recall record does not specify a remedy, so no action is required beyond checking the model number.
The recall record states the hazard may cause resistance during assembly, but does not mention serious injury risk.
We’ve drafted a message you can send Ortho Development to request your refund or repair — edit it as you like.
Subject: Recall Z-1904-2020 — Ortho Development Ortho Development Hello, I own a Ortho Development that is covered by recall Z-1904-2020 from Ortho Development. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
