Reported Jun 21, 2017 · Terminated
Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA…
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?
- Z NAIL PF 14MM X 46CM UNIV Z NAIL GT 14MM X 46CM R Z NAIL GT 14MM X 46CM L Z NAIL TIBIA 14MM X 38CM UNIV Z NAIL TIBIA 14MM X 40CM UNIV Z NAIL TIBIA 14MM X 42CM UNIV Z NAIL TIBIA 14MM X 44CM UNIV
- Lot codes and dates
- 510K:K083497
- K082770 Item Numbers47249146014 47249246014 47249246114 47249538014 47249540014 47249542014 47249544014
- Lot Numbers
94 of 94 codes
6110329061103290V611386716113868261138671V61138682V611386766113868761138676V61138687V6110328761103287V611032816110328361103281V61103283R61103283V61180209112352612028076120584261202807R61205842R6120280861202808R612058466118735061187350R6121827661218276R612166156122306161230526612293966122940761229396R61229407R61245120612451556126097211291961237017612634946126097061260970R612564296127371161187351612737176127726361187351R61279018612894416127724761283862612838731129521127746130159361306420
- Amount recalled
- 1707
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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