CLASS II Device recall · Reported 24 Dec 2014 · FDA Enforcement Report

Brand Name recalled by Biomet

Biomet is recalling Brand Name. The recall was initiated on 2 Dec 2014 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesSirius Polish Cemented Stem 348 Catalog Number: 51-199333 Lot Number Identification: 024320

Quantity recalled9

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-0822-2015
FDA event ID: 69932
Recalling firm: Biomet, Warsaw, IN
Classification: Class II
Status: Terminated
Recall initiated: 2 Dec 2014
FDA classified: 17 Dec 2014
Reported: 24 Dec 2014
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Foreign Material
Device type: Hip & Knee Implants

Timeline

2 Dec 2014	Recall initiated by company
17 Dec 2014	Classified by FDA	+15 days
24 Dec 2014	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

After receiving a complaint, Biomet Orthopedic Inc., conducted an investigation which determined that the following parts were mixed up prior to packaging and shipment: Sirius Polish Cemented Stem 34B Catalog Number: 51-199333, Lot Number Identification: 024320 and Sirius Polish Cemented Stem 38C, Catalog Number: 51-199335, Lot Number Identification: 141680, 180920.

Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.

Product as listed by the FDA

Device Brand Name: Sirius Polish Cemented Stem 34B Device Classification Name: prosthesis, hip, semi-constrained, metal/polymer, cemented Device Common Name: Sirius Femoral Stem The Biomet's Sirius Femoral Hip Stem is a double-tapered, highly polished cemented hip stem, designed for either primary or revision surgery. A distal centralizer is provided for optimal placement within the femoral canal. The system is used with Type 1 taper modular heads and compatible acetabular shells/liners and screws to provide a total hip replacement system.

Where it was distributed

Foreign Distribution in China and Australia only.

Questions about this recall

Is Brand Name recalled?

Yes. Biomet recalled Brand Name on 2 Dec 2014. The recall is Class II and its status is Terminated. Recall number Z-0822-2015.

Why was it recalled?

Which lots are affected?

Sirius Polish Cemented Stem 348 Catalog Number: 51-199333 Lot Number Identification: 024320

Where was it sold?

Foreign Distribution in China and Australia only.

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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