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4-Traders Homepage  >  Equities  >  Nyse  >  Zimmer Biomet Holdings Inc    ZBH

Delayed Quote. Delayed  - 09/30 04:57:54 pm
129.75 USD   +1.49%
09/22 ZIMMER BIOMET : Sep 22, 2016 Zimmer Biomet Contributes Additional $1..
09/21 ZIMMER BIOMET H : ex-dividend day
09/20 ZIMMER BIOMET : Sep 20, 2016 Zimmer Biomet Launches VANGUARD® Indivi..
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Zimmer Holdings, Inc. : Zimmer Receives FDA Warning on Certain Hip Implants

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10/02/2012 | 12:40am CEST

--Zimmer says FDA inspection of Puerto Rico plant turned up concerns about manufacturing of certain implants

--FDA in letter noted manufacturing, testing issues related to Trilogy Acetabuar System products, company says

--Zimmer says it is notifying customers of manufacturing issue, but hasn't withdrawn any products

(Adds context on metallic spikes in fourth paragraph and a no comment from Zimmer in seventh paragraph.)

 
   By Kristin Jones 
 

Zimmer Holdings Inc. (ZMH) said a U.S. Food and Drug Administration inspection of its plant in Puerto Rico turned up concerns about the manufacturing of certain hip implants.

The orthopedic maker's Zimmer Inc. subsidiary received a warning letter from the FDA dated Sept. 19, the company said in a regulatory filing Monday. In the letter, the FDA noted manufacturing and testing issues related to the company's Trilogy Acetabular System products, which are implanted in hip-replacement surgery.

Specifically, the U.S. drug regulator noted that Zimmer hadn't implemented a testing mechanism to show that its products met design specifications. The company also hadn't validated the effect of certain manufacturing operations on Trilogy products that incorporate metallic spikes.

Spikes are used to connect the hip replacement cup to a patient's bone when cement and screws are deemed insufficient.

The FDA requires that drug and medical-device makers undertake steps to ensure the quality of the design and manufacture of its products, known as process validation.

Zimmer said it is notifying customers of the manufacturing issue, but that it hasn't withdrawn any products. The company also said it previously suspended release of the spiked products, pending validation of the processes cited in the letter, and expects to complete validation in the next few weeks.

A Zimmer spokesman declined to comment further.

Shares gained 11 cents to $67.98 in after-hours trading. Through Monday's close, the stock was up 27% so far this year.

--Joseph Walker contributed to this article.

Write to Kristin Jones at kristin.jones@dowjones.com

Subscribe to WSJ: http://online.wsj.com?mod=djnwires

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Financials ($)
Sales 2016 7 703 M
EBIT 2016 2 472 M
Net income 2016 547 M
Debt 2016 10 046 M
Yield 2016 0,72%
P/E ratio 2016 50,83
P/E ratio 2017 19,32
EV / Sales 2016 4,62x
EV / Sales 2017 4,26x
Capitalization 25 570 M
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Mean consensus OUTPERFORM
Number of Analysts 28
Average target price 141 $
Spread / Average Target 11%
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NameTitle
David C. Dvorak President, Chief Executive Officer & Director
Larry C. Glasscock Non-Executive Chairman
Robin T. Barney Senior VP-Global Operations & Logistics
Daniel P. Florin Chief Financial Officer & Senior Vice President
David J. Kunz VP-Global Quality, Clinical & Regulatory Affairs
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