Z-1904-2020Class II

Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V

Name: Z-1904-2020 Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V
Creator: Ortho Development Corporation
Published: 2019-05-30
License: https://open.fda.gov/license/

Ortho Development Corp. / initiated 2019-05-30 / Open, Classified / root cause: manufacturing process

FDA source

Ortho Development Corporation began a recall of Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V on 2019-05-30. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Open, Classified, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1904-2020
Classification: Class II
Status: Open, Classified
Initiated: 2019-05-30
Posted: 2020-05-06
Recalling firm: Ortho Development Corp.
Product: Tibial Tray Nonporous A Size 4; Model # PN 162-1400-A Material: Ti6Al4V.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: 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.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm notified their US sales managers via teleconference on 07/19/2019. The sales managers coordinated distribution of the notification letter to the distributors and surgeons. All 12 US surgeons received both in-person verbal and written notices (hand delivered by sales reps) subsequent to the 07/19/2019 teleconference meeting. Recall actions for products sold in Japan were coordinated by the firm's parent company. In the firm's "Urgent Advisory Notice/Medical Device Recall Notice", dated 07/16/2019 includes the following instructions for end users: Contacting affected patients should be at the discretion of the surgeon to discuss the risks identified. The surgeon should weigh the risk of removing an implanted device against the risk of leaving it in place. Absence of clinical failure should be considered during the decision-making process. The appropriate action is left to the judgment of the surgeon and the preference of the patient. Complete and return the Customer Acknowledgement form. For any questions or concerns, call 801-553-9991 or contact via email at [email protected].
Quantity in commerce: 29
Distribution: US: CA, FL, OH, PA, TX, and UT. OUS: Japan.
Product codes and lots: Lot Number: A204324

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1904-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1903-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-13	2020-05-05
Z-1904-2020	Class II	Ongoing	Voluntary: Firm initiated	2020-05-13	2020-05-05

Product code JWH

K994370Class IIOrtho Development Balanced Knee SystemOrtho Development Corp. / cleared 2000-03-24

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)