Ortho Development Recalls Tibial Tray Components Due to Manufacturing Defect
Ortho Development Corporation is recalling 29 tibial tray components due to a manufacturing defect that may cause assembly resistance.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text describes a manufacturing defect causing assembly resistance without reporting any injuries, illnesses, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk issues or voluntary precautionary actions where harm has not been reported.
Plain-English summary
Ortho Development Corporation is recalling 29 units of the Tibial Tray Nonporous A Size 4 (Model # PN 162-1400-A). The product is made of Ti6Al4V material and is identified by Lot Number A204324.
The recall is due to a manufacturing defect in the locking mechanism of the tibial tray. A uniform ridge was cut along the inner wall of the "T" and "Y" junctions, which may cause resistance when the Tibial Insert is being assembled.
The affected units were distributed in the United States to California, Florida, Ohio, Pennsylvania, Texas, and Utah, as well as in Japan. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
- Manufacturer
- Ortho Development Corporation
- Affected units
- 29
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot Number: A204324
Distribution
Part of a larger recall action
This product is one of 2 recalled by Ortho Development Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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