CLASS II ONGOING Device recall · Reported 23 Feb 2022 · FDA Enforcement Report

Dall Miles SM Grip And 2 Homog Cbl recalled by Howmedica Osteonics

Howmedica Osteonics is recalling Dall Miles SM Grip And 2 Homog Cbl, distributed in Puerto Rico. The recall was initiated on 21 Dec 2021 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesUDI: 07613327013306; Lot Number: 87458602

Quantity recalled1 unit

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-0645-2022
FDA event ID: 89456
Recalling firm: Howmedica Osteonics, Mahwah, NJ
Classification: Class II
Status: Ongoing
Recall initiated: 21 Dec 2021
FDA classified: 16 Feb 2022
Reported: 23 Feb 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Other Medical Devices

Timeline

21 Dec 2021	Recall initiated by company
16 Feb 2022	Classified by FDA	+57 days
23 Feb 2022	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

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

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

Dall Miles SM GRIP AND 2 1.6MM HOMOG CBL, Catalog Number 6704-0-110

Where it was distributed

Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.

Puerto Rico

Questions about this recall

Why was it recalled?

There is a potential for the outer Tyvek lid to de-bond from the sealed package.

Which lots are affected?

UDI: 07613327013306; Lot Number: 87458602

Where was it sold?

Worldwide distribution - US Puerto Rico and the countries of Canada, and Malaysia.

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 89456

This product is part of a recall event; the main page for the event is 4 V40 Taper Vit Head recalled by Howmedica Osteonics.

Reported	Class	Recall	Company	Reason	Where
23 Feb 2022	CLASS II	4 V40 Taper Vit Head recalled by Howmedica Osteonics	Howmedica Osteonics	Packaging Defects	PR

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