FDAClass IINovember 28, 2012

Ranawat/Burnstein Acetabular Shell 54mm/Limited recall

Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The…

Why was Ranawat/Burnstein Acetabular Shell 54mm/Limited recalled?

The color code on label conflicts with the liner size (liner size 24 should be green, not yellow)

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?

Part 11-106054 Lot 528310

Product
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere, acetabular shell component. Intended Use: The…
Recalling firm
Biomet, Inc.
Quantity
16 (5 USA)
Distribution
Nationwide Distribution including CA, IN, NC, OH, and UT.
Recall date
November 28, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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