Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

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

SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector newsTweets 

Zimmer Holdings, Inc. : Zimmer Receives FDA Warning on Certain Hip Implants

share with twitter share with LinkedIn share with facebook
share via e-mail
0
10/02/2012 | 12:40am CET

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--Zimmer says it is notifying customers of manufacturing issue, but hasn't withdrawn any products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Zimmer said it is notifying customers of the manufacturing issue, but that it hasn't withdrawn any products.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

share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on ZIMMER BIOMET HOLDINGS INC
01/21 ZIMMER BIOMET : Nominee-tied firm flagged in bribery
01/20 ZIMMER BIOMET HOLDINGS INC : ZBH SHAREHOLDER DEADLINE ALERT: Lundin Law PC Annou..
01/19 LIFSHITZ & MILLER LAW FIRM : Announces Investigation of Ally Financial Inc., Amp..
01/19 ZIMMER BIOMET : Company that HHS pick invested in faced criminal penalty
01/19 ZIMMER BIOMET : Company that Trump HHS pick invested in faced criminal fine
01/19 ZIMMER BIOMET HOLDINGS INC : Khang & Khang LLP Announces Securities Class Action..
01/19 ZBH The Law Offices of Vincent Wong Reminds Investors of a Class Action Invol..
01/18 ZIMMER BIOMET HOLDINGS INC : ZBH INVESTOR DEADLINE ALERT: Lundin Law PC Announce..
01/18 ZIMMER BIOMET : GPM Reminds Investors of the January 31 Deadline in the Class Ac..
01/18 ZIMMER BIOMET HOLDINGS, INC. : Change in Directors or Principal Officers, Financ..
More news
Sector news : Medical Equipment, Supplies & Distribution - NEC
01/17DJLUXOTTICA FOUNDER : A Lifetime of Deals -- WSJ
01/17DJLUXOTTICA : Merger to Create Eyewear Giant -- WSJ
01/17DJWHAT'S NEWS : Business & Finance -- WSJ
01/16 ESSILOR INTL : Luxottica's merger helps Del Vecchio manage family risks
01/16DJLUXOTTICA : Another Big Splash by Italy's Eyewear King
More sector news : Medical Equipment, Supplies & Distribution - NEC
News from SeekingAlpha
01/21 D.R. Horton, Shell, FCX, senior loans among picks at Barron's Roundtable
01/20 DIVIDEND CHALLENGERS (AND NEAR-CHALL : 124 Increases Expected By March 31
01/18 Zimmer Biomet appoints new chief of Americas business
01/12 Zimmer Biomet resolves FCPA issues with DOJ and SEC, agrees to pay $30.5M
01/11 Medtech Mergers And Acquisitions Regresses To The Mean In 2016
Advertisement
Financials ($)
Sales 2016 7 651 M
EBIT 2016 2 392 M
Net income 2016 508 M
Debt 2016 10 627 M
Yield 2016 0,82%
P/E ratio 2016 50,96
P/E ratio 2017 18,20
EV / Sales 2016 4,36x
EV / Sales 2017 4,07x
Capitalization 22 764 M
More Financials
Chart ZIMMER BIOMET HOLDINGS INC
Duration : Period :
Zimmer Biomet Holdings Inc Technical Analysis Chart | ZBH | US98956P1021 | 4-Traders
Full-screen chart
Technical analysis trends ZIMMER BIOMET HOL...
Short TermMid-TermLong Term
TrendsBullishNeutralNeutral
Technical analysis
Income Statement Evolution
More Financials
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 27
Average target price 130 $
Spread / Average Target 15%
Consensus details
EPS Revisions
More Estimates Revisions
Managers
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
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
ZIMMER BIOMET HOLDINGS..10.13%22 764
MEDTRONIC PLC5.28%102 965
BAXTER INTERNATIONAL I..4.26%25 145
C R BARD INC3.03%17 018
HOYA CORPORATION-4.53%15 970
TERUMO CORP-1.50%14 109
More Results