FDAClass IINovember 14, 2012

Anatomical Shoulder" Fracture Humeral stem recall

Anatomical Shoulder" Fracture Humeral stem

Why was Anatomical Shoulder" Fracture Humeral stem recalled?

Zimmer Inc., is initiating a correction to the patient labels of products manufactured before March 20I0 by the Zimmer GmbH production site in Wintetthur, Switzerland, after receiving four complaints of a discrepancy between product patient labels and product labels with respect to the reference and lot numbers of the product. While the information printed on the product label is correct, the info

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?

REF Numbers: 01.04207.072, 01.04207.082, 01.04207.092, 01.04207.112, 01.04207.132, 01.04207.142, 01.04217.072, and 01.04217.132. Lot 2360479, 2373842, 2331163, 2401526, 2458833, 2360473, 2451660, 2387138, 2521377, 2342166, 2455419, 2342646, 2436406, 2362563, 2413744, 2423092, 2423094, 2472576, 2433869,

Product
Anatomical Shoulder" Fracture Humeral stem
Recalling firm
Zimmer, Inc.
Quantity
139
Distribution
Nationwide Distribution.
Recall date
November 14, 2012
Classification
Class II
Status
Terminated
Agency
FDA (device)
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