Reported Mar 23, 2016 · Terminated
Product 51 consists of all product under product code: JWH and same usage: Item no: 598603701 NEXGEN OPTION STEMMED TIB…
Zimmer Manufacturing B.V.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Zimmer Manufacturing B.V. · Turpeaux Industrial Park Rd 1 km 123.4 · Mercedita, PR · 00715
Is this the product you have?
- Product 51 consists
- of all product under product codeJWH
- and same usageItem
- no598603701 NEXGEN OPTION STEMMED TIB 598603702 NEXGEN OPTION STEMMED TIB 598604701 NEXGEN OPTION STEMMED TIB 598604702 NEXGEN OPTION STEMMED TIB 598605701 NEXGEN OPTION STEMMED TIB 598605702 NEXGEN OPTION STEMMED TIB for use in total knee arthroplasty
- Lot codes and dates
- lot no.:
1,263 of 1,263 codes
616278586166759461687053616870576171162761711636617116386171164061711642617875586178755961787560617875616178756261791460617914626179146461791466617914676179146861797925617979266179792761797928617979296179793061797931617979326179793361809215618092166180921761809218618092196181655361820496618204976182049861823244618232456182324661823247618232486182931461829315618293166182931761829318618381866183818761838188618381896183819061850512618505136185051561850516618505176186139161861392
- lot no.:
- Amount recalled
- 29525
This recall covers 72 products
The agency filed one notice per product. You are reading one of them; the other 71 are below.
59 more are in the archive.
Where it was sold
- Nationwide
Why it was recalled
As a result of the insufficient sealer calibration data for product packaged in firm's Building II between August 2010 and April 2013. The affected products are sterile.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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