Reported Jun 21, 2017 · Terminated
VERSA-FXII SC TUBE PLT 90DX16H, 95DX16H, 95DX18H, 95DX20H, 95DX22H
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?
VERSA-FXII SC TUBE PLT 90DX16H95DX16H95DX18H95DX20H95DX22H
- Lot codes and dates
- I10KK954555
- K150818 Item Numbers
0011930901600119309516001193095180011930952000119309522
- Lot Numbers
6074613260746132R6069948160699481R6081239860812398R6084407260844072R6082057660868450368893368898368898R36891736891636889961577082619894163709076189593761895939371034622797186235155962445941624459426251127862539606372143603721435437214361371091283710908162931489629315296293052963009490630795606356492863594628
- Amount recalled
- 445
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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