Reported Jun 21, 2017 · Terminated
R-F IM NAIL 10MMDX48CM LG, 11MMDX42CM, 11MMDX44CM, 11MMDX46CM LG, 11MMDX48CM LG, 12MMDX46CM LG, 12MMDX48CM LG,…
Zimmer Biomet, Inc.
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 Biomet, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
R-F IM NAIL 10MMDX48CM LG11MMDX42CM11MMDX44CM11MMDX46CM LG11MMDX48CM LG12MMDX46CM LG12MMDX48CM LG13MMDX40CM13MMDX42CM13MMDX44CM13MMDX46CM LG13MMDX48CM LG14MMDX34CM14MMDX36CM14MMDX38CM14MMDX40CM14MMDX42CM14MMDX44CM14MMDX46CM LG14MMDX48CM LG
- Lot codes and dates
510K: K965098K142281
- K962561 Item Numbers
0022400104800224001142002240011440022400114600224001148002240012460022400124800224001340002240013420022400134400224001346002240013480022400143400224001436002240014380022400144000224001442002240014440022400144600224001448
- Lot Numbers
297 of 297 codes
606775686068498360677568R60684983R6067002660670026R6064575060645750R6069165560691655R6071147160711471R6071508160715081R6072513960725139R6075480460754804R607474766074746260747462R6074747760815078608150796081618160815078R60815079R60816181R6081618060816180R6082025336718636718960822094367186R367189R60822094R367810367810R6083900660837666608441636084419660837666R60844163R60844196R367869367871367869R608487016085408060848701R60854080R6085407960854079R367829367829R60859062368307368310
- Amount recalled
- 3856
This recall covers 43 products
The agency filed one notice per product. You are reading one of them; the other 42 are below.
30 more are in the archive.
Where it was sold
Why it was recalled
Zimmer Biomet is initiating a field action for sterile-packaged implants packaged in a single package configuration due to packaging design verification test failures.
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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