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.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
Same manufacturer · Ortho Development Corporation
See all →- HighOrtho Development Recalls Tibial Tray Due to Manufacturing Defect
FDA (Devices) · 2020-05-13
- SevereOrtho Development Recalls Knee Implants Due to Improper Foil Pouch Sealing
FDA (Devices) · 2014-08-27
- SevereOrtho Development Recalls Knee Implant Components Due to Sealing Defects
FDA (Devices) · 2014-08-27
- HighOrtho Development Recalls Knee Implants Due to Improper Foil Pouch Seals
FDA (Devices) · 2014-08-27
- HighOrtho Development Recalls Knee Implants Due to Improperly Sealed Foil Pouches
FDA (Devices) · 2014-08-27
Same hazard · manufacturing defect
See all →- ModerateNeuronetics Recalls NeuroStar Advanced Therapy Systems Due to Non-Conforming Cables
FDA (Devices) · 2026-10-21
- ModerateBoston Scientific Recalls NaviFlex LW Pusher and Advx Panc. Stent
FDA (Devices) · 2026-10-21
- ModerateCook Williams Cystoscopic Injection Needles Recalled for Manufacturing Defect
FDA (Devices) · 2026-10-21
- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-10-14
- ModerateCustom Interventional Pain Management Recalls Mastisol Skin Adhesive Trays
FDA (Devices) · 2026-10-07
Similar recalls
- HighStryker INBONE Tibial Tray Recalled Due to Oversized Lock Detail
FDA (Devices) · 2022-11-02
- HighExactech Recalls Optetrak Offset Tibial Tray Due to Design Incompatibility
FDA (Devices) · 2017-11-29
- HighStryker INBONE Tibial Tray recalled for oversized lock detail defect
FDA (Devices) · 2022-11-02
- HighExactech Recalls Optetrak Offset Tibial Trays Due to Design Incompatibility
FDA (Devices) · 2017-11-29
- ModerateArthrex Recalls Tibial Opening Wedge Osteotomy Plates Due to Processing Error
FDA (Devices) · 2021-04-21
- HighExactech Recalls Optetrak Offset Tibial Tray and Screws Due to Design Incompatibility
FDA (Devices) · 2017-11-29