The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0139-2023·Announced 2022-11-02

Stryker INBONE Tibial Tray Recalled Due to Oversized Lock Detail

Stryker INBONE Tibial Trays are being recalled due to an oversized lock detail that could affect proper component assembly and implant function. Affected units were distributed in New York.

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: This is a Class II medical device recall involving a manufacturing defect in a critical structural component. The oversized lock detail poses a risk of improper component seating and device malfunction. No illnesses or injuries have been reported, meeting the rubric criterion for risk-of-harm products where injury has not yet been reported.

Plain-English summary

Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, Use w/ 16mm Stem Base (REF 200252903, Size 3) is being recalled by Wright Medical Technology, Inc. The recall is due to a manufacturing defect in which the tibial tray lock detail measures larger than the design specification.

One unit with Lot Code 1726308 was distributed in New York. The oversized lock detail could affect the proper fit and function of the component during surgery or subsequent use.

Patients or healthcare providers who received this device should contact Wright Medical Technology, Inc., or their healthcare provider for guidance on what actions, if any, are appropriate. For additional information about this recall, contact the FDA.

The recalled product

Product
Stryker INBONE Tibial Tray, Left Plasma Spray Ti6Al4V, CPti, Use w/ 16mm Stem Base, REF 200252903, Size 3
Manufacturer
Wright Medical Technology, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
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 00840420124142
  • Lot Code: 1726308

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 →

Related recalls

Same manufacturer · Wright Medical Technology, Inc.

See all →

Same hazard · manufacturing defect

See all →

Similar recalls