Reported Mar 23, 2016 · Terminated
Product 70 consists of all product under product code: JDI and same usage: Item no: 785701000 VERSYS HERITAGE FEM STEM…
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 70 consists
- of all product under product codeJDI
- and same usageItem
- no785701000 VERSYS HERITAGE FEM STEM 785701100 VERSYS HERITAGE FEM STEM 785701200 VERSYS HERITAGE FEM STEM 785701300 VERSYS HERITAGE FEM STEM 785701320 VERSYS HERITAGE FEM STEM 785701400 VERSYS HERITAGE FEM STEM 785701420 VERSYS HERITAGE FEM STEM 785701500 VERSYS HERITAGE FEM STEM 785701520 VERSYS HERITAGE FEM STEM 785701600 VERSYS HERITAGE FEM STEM 785701700 VERSYS HERITAGE FEM STEM For use in total or hemi hip arthroplasty
- Lot codes and dates
- lot no.:
84 of 84 codes
61661156619665786222573561873650619628586213722762137228622407626234006062340060N618208236188119361957419619628556217204762175238622344606226278762291935622982916229829262310454623146566234005862298291N62310454N62314656N62340058N6187846761881194618833976188693961899754619680106222100862284504622852726229193762291937N61822322620321806226012862304808623400626235889662304808N62340062N61813932618208196198016862205493622402636224077162240772622407736224077462282932622911386229193862296576
- lot no.:
- Amount recalled
- 360
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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