Ortho Development Recalls Tibial Tray Due to Manufacturing Defect
Ortho Development Corporation is recalling 27 units of Tibial Tray Nonporous A Size 2 due to a manufacturing defect in the locking mechanism that may cause assembly resistance.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a functional defect in a medical device that could impede proper assembly, representing a risk of harm where injury has not yet been reported.
Plain-English summary
Ortho Development Corporation is recalling 27 units of the Tibial Tray Nonporous A Size 2 (Model # PN 162-1200-A). The product is made of Ti6Al4V material and is identified by Lot Number A200590.
The recall was initiated because the locking mechanism of the tibial tray exhibited a manufacturing defect. Specifically, a uniform ridge was cut along the inner wall of the "T" and "Y" junctions. This defect 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. Healthcare providers and facilities should stop using the affected devices and contact the recalling firm for further instructions.
The recalled product
- Product
- Tibial Tray Nonporous A Size 2; Model # PN 162-1200-A; Material: Ti6Al4V.
- Manufacturer
- Ortho Development Corporation
- Affected units
- 27
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: A200590
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 →- ModerateOrtho Development Recalls Tibial Tray Components 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 →- HighBeak & Skiff Alcohol Antiseptic Sanitizer recalled for acetaldehyde contamination
FDA (Drugs) · 2026-09-02
- HighSun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
- HighKnee Prosthesis Trial Recall for Manufacturing Defect
FDA (Devices) · 2026-08-12
- HighU2 Total Knee System Femoral Valgus Adaptor Recall
FDA (Devices) · 2026-08-12
- HighUSTAR II Knee System Hinge Box Trial Recall
FDA (Devices) · 2026-08-12