FDAClass IIDecember 24, 2014

Sirius Polish Cemented Stem 38C recall

Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a…

Why was Sirius Polish Cemented Stem 38C recalled?

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 348 Catalog Number: 51-199333, Lot Number Identification: 024320 and Sirius Polish Cemented Stem 38C, Catalog Number: 51-199335, Lot Number Identification: 141680, 180920.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920

Product
Sirius Polish Cemented Stem 38C Catalog Number: 51-199335 Lot Number Identification: 141680, 180920 The Biomet's Sirius Femoral Hip Stem is a…
Recalling firm
Biomet, Inc.
Quantity
8
Distribution
Foreign Distribution in China and Australia only.
Recall date
December 24, 2014
Classification
Class II
Status
Terminated
Agency
FDA (device)
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