Z-1924-2020Class II

WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 -

Name: Z-1924-2020 WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 -
Creator: Wright Medical Technology Inc
Published: 2020-04-09
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2020-04-09 / Terminated / root cause: manufacturing process

FDA source

Wright Medical Technology Inc began a recall of WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain... on 2020-04-09. FDA classified it as Class II and gives the reason as "One lot of INBONE Tibial Trays is missing the plasma coating". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1924-2020
Classification: Class II
Status: Terminated
Initiated: 2020-04-09
Posted: 2020-05-07
Terminated: 2020-11-02
Recalling firm: Wright Medical Technology Inc
Product: WRIGHT INBONE Tibial Tray, Size: 2, Plasma Spray, Left, REF 2000252902 - Product Usage: is intended to give a patient limited mobility by reducing pain, restoring alignment and replacing the flexion and extension movement in the ankle joint.
Product code: HSN Prosthesis, Ankle, Semi-Constrained, Cemented, Metal/Polymer
Reason for recall: One lot of INBONE Tibial Trays is missing the plasma coating.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: The firm initiated the recall by letter on 04/09/2020. The letter requested the consignee immediately cease use and quarantine the product for return.
Quantity in commerce: 22 units
Distribution: US Nationwide distribution.
Product codes and lots: Lot code 1619947

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1924-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1924-2020	Class II	Terminated	Voluntary: Firm initiated	2020-05-13	2020-05-07

Product code HSN

K051023Class IITopez Total Ankle ReplacementTopez Orthopedics, Inc. / cleared 2005-11-15

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)