CLASS II Device recall · Reported 25 Feb 2015 · FDA Enforcement Report

Mallory Head 4 Finned Acetabular Shell, PN recalled by Biomet

Biomet is recalling Mallory Head 4 Finned Acetabular Shell, PN 13-104150, hip prosthesis component (Ringloc), distributed in Texas, Virginia. The recall was initiated on 9 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesCatalog Number: 13-104150 Lot Number Identification: 364600

Quantity recalled17

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-1122-2015
FDA event ID: 70438
Recalling firm: Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 9 Jan 2015
FDA classified: 17 Feb 2015
Reported: 25 Feb 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Device type: Hip & Knee Implants

Timeline

9 Jan 2015	Recall initiated by company
17 Feb 2015	Classified by FDA	+39 days
25 Feb 2015	Published in enforcement report	+8 days

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

Reason for recall

Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

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

Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)

Where it was distributed

Distributed in the states of VA and TX and the country of Japan.

Texas Virginia

Questions about this recall

Is Mallory Head 4 Finned Acetabular Shell, PN 13-104150, hip prosthesis component (Ringloc) recalled?

Yes. Biomet recalled Mallory Head 4 Finned Acetabular Shell, PN 13-104150, hip prosthesis component (Ringloc) on 9 Jan 2015. The recall is Class II and its status is Terminated. Recall number Z-1122-2015.

Why was it recalled?

Biomet recalled the Mallory Head 4 Finned Acetabular Shell 50mm (Lot 364600) and Ringloc + Acetabular Shell Limited Hole Finned 52 mm (Lot 427840) following a mix up in packaging with the two.

Which lots are affected?

Catalog Number: 13-104150 Lot Number Identification: 364600

Where was it sold?

Distributed in the states of VA and TX and the country of Japan.

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

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