Agency classClass IIOur severity:High FDA (Devices)·Z-0315-2022·Announced 2021-12-08

INBONE Total Ankle System recalled for package-labeling mismatch

Wright Medical Technology is recalling INBONE Total Ankle System implants because the package contents and package labeling do not match.

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 an FDA Class II recall of a surgical implant with a mismatch between package contents and labeling. Although no illnesses or injuries have been reported, the condition presents a risk of harm through potential incorrect implant selection, meeting the Score 3 criteria of risk-of-harm products where injury has not yet been reported.

Plain-English summary

Wright Medical Technology Inc is recalling INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS implants due to a mismatch between the package contents and package labeling.

The package contents and package labeling do not match, which creates a potential for confusion or incorrect implant selection during surgical procedures.

The affected product is Model 220222210E, Lot Code 05113580751661825 (GTIN: 00840420124968). Two units have been quarantined. The product received US Nationwide distribution in Michigan and Pennsylvania.

Healthcare facilities and providers that have received this product should contact Wright Medical Technology Inc for further information and instructions regarding the package mismatch.

The recalled product

Product: INBONE Total Ankle System, INBONE POLY INSERT SZ 2 10mm SULCUS
Manufacturer: Wright Medical Technology Inc
Category: Medical Device — Orthopedic Implant
Hazard: mis-labeling
package-mismatch

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)

Model 220222210E
Lot Code 05113580751661825 (GTIN: 00840420124968)

Distribution

Distributed nationwide across the United States.

The notice also names 2 states 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

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Same hazard · mis labeling