CLASS II Device recall · Reported 8 Dec 2021 · FDA Enforcement Report

Inbone Total Ankle System, Inbone Poly Insert SZ 2+ Sulcus recalled

Wright Medical Technology is recalling Inbone Total Ankle System, Inbone Poly Insert SZ 2+ Sulcus, distributed nationwide in the US. The recall was initiated on 4 Nov 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 220223214E, Lot Code 06113718691661809 (GTIN: 00840420125033)

Quantity recalled2 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-0316-2022
FDA event ID: 89007
Recalling firm: Wright Medical Technology, Arlington, TN
Classification: Class II
Status: Terminated
Recall initiated: 4 Nov 2021
FDA classified: 1 Dec 2021
Reported: 8 Dec 2021
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

4 Nov 2021	Recall initiated by company
1 Dec 2021	Classified by FDA	+27 days
8 Dec 2021	Published in enforcement report	+7 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The package contents and package labeling do not match.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

INBONE Total Ankle System, INBONE POLY INSERT SZ 2+ 14mm SULCUS

Where it was distributed

US Nationwide distribution in the states of MI and PA.

Nationwide Michigan Pennsylvania

Questions about this recall

Why was it recalled?

The package contents and package labeling do not match.

Which lots are affected?

Model 220223214E, Lot Code 06113718691661809 (GTIN: 00840420125033)

Where was it sold?

US Nationwide distribution in the states of MI and PA.

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

1 other product · FDA event 89007

Reported	Class	Recall	Company	Reason	Where
8 Dec 2021	CLASS II	Inbone Total Ankle System, Inbone Poly Insert SZ 2 Sulcus recalled	Wright Medical Technology	Packaging Defects	Nationwide

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