Reported Mar 23, 2016 · Terminated
Product 19 consists of all product code: JDI and same usage: Item no: 765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM…
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 19 consists of all product codeJDI
- and same usageItem
- no765301101 CEM FEM ST 11X120 NOCOAT 765301201 CEM FEM ST 12X125 NOCOAT 765301301 CEM FEM ST 13X130 NOCOAT 765301401 CEM FEM ST 14X135 NOCOAT 765301501 CEM FEM ST 15X140 NOCOAT 765301601 CEM FEM ST 16X145 NOCOAT 763301300 CEM FEM ST FX 13 X 130 763301600 CEM FEM ST FX 16 X 145 For use in total or hemi hip arthroplasty
- Lot codes and dates
- lot no.:
61 of 61 codes
622227636224026662268561622844876229435362310467623201606234656661846909618599306202871562069012621148326223756062278694622844866229829462305946623104636233076762340043618640956202871362038326620860426210067862114831622157046228448862291943623059456231164462317919623201576232015862340044623633646186623762105184622157056226856662284489622943546230351262311645623307686206528762211913622685636228449062299091623201616233399062299091N618858716210067962278695623037036233399262069011
- lot no.:
- Amount recalled
- 0
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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