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    ZBH

ZIMMER BIOMET HOLDINGS (ZBH)
Mes dernières consult.
Most popular
  Report  
SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsofficial PublicationsSector 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 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--Zimmer says it is notifying customers of manufacturing issue, but hasn't withdrawn any products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Zimmer said it is notifying customers of the manufacturing issue, but that it hasn't withdrawn any products.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 [email protected]

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
04/19ZIMMER BIOMET : Announces FDA Clearance and First Surgical Case of the Persona T..
AQ
04/18ZIMMER BIOMET : Oregon Surgical Institute to Implement Zimmer Biomet Signature S..
PR
04/18ZIMMER BIOMET : Hip and Knee Orthopedic Surgical Implants Market Analysis to 202..
AQ
04/16ZIMMER BIOMET : Announces FDA Clearance and First Surgical Case of the Persona® ..
PR
04/13ZIMMER BIOMET HOLDINGS, INC. (NYSE : ZBH) Files An 8-K Departure of Directors or..
AQ
04/13ZIMMER BIOMET HOLDINGS, INC. : Change in Directors or Principal Officers (form 8..
AQ
04/12ZIMMER BIOMET : Announces FDA Clearance of the Comprehensive® Augmented Baseplat..
AQ
04/09ZIMMER BIOMET HOLDINGS, INC. (NYSE : ZBH) Files An 8-K Regulation FD Disclosure
AQ
04/06ZIMMER BIOMET HOLDINGS, INC. : Regulation FD Disclosure (form 8-K)
AQ
04/02ZIMMER BIOMET : Announces FDA Clearance of the Comprehensive® Augmented Baseplat..
PR
More news
News from SeekingAlpha
02:58aVilas Fund, LP Q1 '18 Letter To Partners - #28 Since Inception, Long Pharma 
04/11DIVIDEND STREAKS IN DANGER : April Edition 
04/04Jana loses money in March, but is buying the dip 
03/29Zimmer Biomet's Mobi-C Cervical Disc shows maintains benefit in long-term stu.. 
03/23Premarket analyst action - healthcare 
Financials ($)
Sales 2018 7 966 M
EBIT 2018 2 313 M
Net income 2018 1 072 M
Debt 2018 8 052 M
Yield 2018 0,91%
P/E ratio 2018 22,94
P/E ratio 2019 18,90
EV / Sales 2018 3,82x
EV / Sales 2019 3,57x
Capitalization 22 366 M
Chart ZIMMER BIOMET HOLDINGS
Duration : Period :
Zimmer Biomet Holdings Technical Analysis Chart | ZBH | US98956P1021 | 4-Traders
Technical analysis trends ZIMMER BIOMET HOLDINGS
Short TermMid-TermLong Term
TrendsBearishBearishBearish
Income Statement Evolution
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 29
Average target price 138 $
Spread / Average Target 24%
EPS Revisions
Managers
NameTitle
Bryan C. Hanson President, Chief Executive Officer & Director
Larry C. Glasscock Non-Executive Chairman
Adrian Furey Senior VP-Global Operations & Logistics
Daniel P. Florin Chief Financial Officer & Executive Vice President
David J. Kunz VP-Global Quality, Clinical & Regulatory Affairs
Sector and Competitors
1st jan.Capitalization (M$)
ZIMMER BIOMET HOLDINGS-8.23%22 366
MEDTRONIC PLC-0.15%108 687
BAXTER INTERNATIONAL3.43%36 151
ALIGN TECHNOLOGY22.71%22 204
TERUMO CORP13.20%21 478
HOYA CORPORATION1.60%20 663