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--Zimmer says it is notifying customers of manufacturing issue, but hasn't withdrawn any products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Zimmer said it is notifying customers of the manufacturing issue, but that it hasn't withdrawn any products.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
02/16 ZIMMER BIOMET : Announces the International Release of the Innovative Subchondro..
02/10 ZIMMER BIOMET : slicing 1% of its US jobs Warsaw company mum on actual number to..
02/09 ZIMMER BIOMET : Technical Reports on Medical Equipment Equities -- Edwards Lifes..
02/09 Smith & Nephew hurt by tough markets in China and Gulf states
02/07 ZIMMER BIOMET : Feb 7, 2017 Zimmer Biomet Announces the International Release of..
02/07 ZIMMER BIOMET : Feb 7, 2017 Zimmer Biomet Holdings to Present at the LEERINK Par..
02/01 ZIMMER BIOMET : Feb 1, 2017 Zimmer Biomet Announces FDA Approval of Expanded 26-..
01/31DJZIMMER BIOMET : Hip, Knee Businesses Drive Results
01/31 ZIMMER BIOMET : beats 4Q profit forecasts
01/31 ZIMMER BIOMET HOLDINGS, INC. : Results of Operations and Financial Condition, Fi..
More news
Sector news : Medical Equipment, Supplies & Distribution - NEC
02/21DJMEDTRONIC : Earnings Fall, Sales Rise -- Update
02/21 MEDTRONIC : sales, profit beat estimates; shares rise
02/21DJMEDTRONIC : Earnings Fall, Sales Rise
02/16 STRAUMANN : on hunt for 3D printer partner, could take stake - CEO
02/09 Smith & Nephew hurt by tough markets in China and Gulf states
More sector news : Medical Equipment, Supplies & Distribution - NEC
News from SeekingAlpha
02/13 DIVIDEND CHALLENGERS (AND NEAR-CHALL : 87 Increases Expected By April 30
02/09 VALUATION DASHBOARD : Healthcare - Update
01/31 Zimmer Biomet Holdings' (ZBH) CEO David Dvorak on Q4 2016 Results - Earnings ..
01/31 Zimmer Biomet Holdings revenues up 4%; non-GAAP EPS up 2% in Q4; updates 2017..
01/31 Zimmer Biomet beats by $0.03, beats on revenue
Advertisement
Financials ($)
Sales 2017 7 886 M
EBIT 2017 2 525 M
Net income 2017 1 165 M
Debt 2017 9 260 M
Yield 2017 0,84%
P/E ratio 2017 23,22
P/E ratio 2018 17,05
EV / Sales 2017 4,15x
EV / Sales 2018 3,88x
Capitalization 23 469 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 134 $
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..13.54%23 469
MEDTRONIC PLC13.10%110 613
BAXTER INTERNATIONAL I..12.67%27 174
C R BARD INC8.27%17 521
HOYA CORPORATION3.11%17 432
DENTSPLY SIRONA INC8.26%14 430
More Results