Ortho Development Corporation recalls Tibial Tray Nonporous A Size 2 (Model PN 162-1200-A) due to a manufacturing defect that may cause resistance during assembly. Affected units include those with Lot Number A200590.
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 Corporation is recalling Tibial Tray Nonporous A Size 2 models (Model # PN 162-1200-A) because a manufacturing defect may cause resistance when assembling the Tibial Insert. This could lead to improper fitting or complications during use.
The locking mechanism has a uniform ridge cut along the inner wall of the "T" and "Y" junctions. This ridge may cause resistance when the Tibial Insert is assembled, potentially leading to improper fitting or complications during use.
Ortho Development's Tibial Tray Nonporous A Size 2 models (Model # PN 162-1200-A) with Lot Number A200590 are affected. Patients using these implants for orthopedic procedures are most at risk.
Check for the model number PN 162-1200-A on the product. The lot number A200590 is also associated with this recall. This product was sold by Ortho Development Corporation.
Verify the model number (PN 162-1200-A) and lot number (A200590) on the product.
The recall is for a manufacturing defect that may cause resistance during assembly, but it does not indicate a risk of serious injury or death. The danger level is low risk.
Check for the model number PN 162-1200-A and lot number A200590 on the product. This product was sold by Ortho Development Corporation.
The recall does not specify a remedy, so no action is required beyond checking if your product matches the model and lot numbers.
We’ve drafted a message you can send Ortho Development to request your refund or repair — edit it as you like.
Subject: Recall Z-1903-2020 — Ortho Development Ortho Development Hello, I own a Ortho Development that is covered by recall Z-1903-2020 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.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
