Agency classClass IIOur severity:High FDA (Devices)·Z-0140-2023·Announced 2022-11-02

Stryker INBONE Tibial Tray recalled for oversized lock detail defect

Wright Medical Technology is recalling one Stryker INBONE Tibial Tray due to an oversized tibial tray lock detail that exceeds product specifications and could affect device functionality.

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 3/5 (High).

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: FDA Class II recall involving a manufacturing defect in an orthopedic implant that presents a risk of device malfunction or failure. No injuries or adverse events have been reported, consistent with the rubric criterion for High severity (risk-of-harm products without reported injury).

Plain-English summary

Wright Medical Technology, Inc. is recalling a single Stryker INBONE Tibial Tray (REF 200252904, Size 4, Lot Code 1725563) that was distributed in New York. The tibial tray lock detail is oversized, exceeding the product's specifications.

This manufacturing defect could compromise the proper fit and function of the knee implant. The oversized lock detail may prevent proper seating or locking of the component, potentially leading to implant failure or unexpected performance issues.

Patients who received this specific implant should contact their healthcare provider or surgeon immediately. Healthcare providers should review patient records to identify anyone who may have received this recalled unit and assess whether clinical intervention is necessary.

No injuries or adverse events associated with this defect have been reported to the FDA as of this notice.

The recalled product

Product: Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 18mm Stem Base, REF 200252904, Size 4
Manufacturer: Wright Medical Technology, Inc.
Category: Medical Device — Orthopedic Implant
Hazard: manufacturing-defect
implant-malfunction
Affected units: 1

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 (2)

GTIN 00840420124159
Lot Code: 1725563

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 2 recalled by Wright Medical Technology, Inc. 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 →

Same manufacturer · Wright Medical Technology, Inc.

See all →

High
Wright Medical Recalls Charlotte Claw Screws Due to Missing Threads
FDA (Devices) · 2026-10-07
High
Stryker Infinity Resection Adjustment Block Recall: Missing Locking Screw
FDA (Devices) · 2024-04-10
High
Stryker Infinity Alignment Frame Distal Sub-Assembly Recalled for Manufacturing Defect
FDA (Devices) · 2023-07-12
High
Stryker ORTHOLOC 3Di Fusion Plate Contains Incorrect Laser Markings
FDA (Devices) · 2023-05-03
High
Stryker ORTHOLOC 3Di Fusion Plate Recalled for Incorrect Marked Descriptions
FDA (Devices) · 2023-05-03

Same hazard · manufacturing defect