Reported Sep 3, 2014 · Terminated
Endo & Unipolar Femoral Heads: ENDO FEMORAL HEAD 43MM DIA, ENDO FEMORAL HEAD 53MM DIA, ENDO FEMORAL HEAD 47MM DIA, ENDO…
Zimmer, 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, Inc. · 1800 W Center St · Warsaw, IN · 46580-2304
Is this the product you have?
- Endo & Unipolar Femoral Heads
ENDO FEMORAL HEAD 43MM DIAENDO FEMORAL HEAD 53MM DIAENDO FEMORAL HEAD 47MM DIAENDO FEMORAL HEAD 50MM DIAENDO FEMORAL HEAD 42MM DIAENDO FEMORAL HEAD 54MM DIAENDO FEMORAL HEAD 48MM DIAENDO FEMORAL HEAD 41MM DIAENDO FEMORAL HEAD 42MM DIAENDO FEMORAL HEAD 43MM DIAENDO FEMORAL HEAD 44MM DIAENDO FEMORAL HEAD 45MM DIAENDO FEMORAL HEAD 46MM DIAENDO FEMORAL HEAD 47MM DIAENDO FEMORAL HEAD 48MM DIAENDO FEMORAL HEAD 49MM DIAENDO FEMORAL HEAD 50MM DIAENDO FEMORAL HEAD 51MM DIAENDO FEMORAL HEAD 52MM DIAENDO FEMORAL HEAD 53MM DIAENDO FEMORAL HEAD 54MM DIAENDO FEMORAL HEAD 55MM DIA
- Lot codes and dates
- Item Numbers
00781804300007818053000078180470000781805000007818042000078180540000781804800007818041000078180420000781804300007818044000078180450000781804600007818047000078180480000781804900007818050000078180510000781805200007818053000078180540000781805500
- Lot Numbers
3721095837210967372111803721118337211311372113163721132037211379372114826256148437211643372116453721164637211647372116533721165537211657372116583721166137211801372118043721180537211806372118113721181237211815372118173721182037212062372120633721206537212074372120796257357462573576625760026257600862593298625933023721260837211644
- Item Numbers
- Amount recalled
- 972,125 units
This recall covers 9 products
The agency filed one notice per product. You are reading one of them; the other 8 are below.
Why it was recalled
Zimmer is recalling sterile-packaged implants and instruments packaged in six different package configurations due to packaging design verification test failures. Specifically, multiple test samples from each of the six configurations failed simulated distribution and shipping testing when the devices either breached inner or outer package trays or seal integrity was lost.
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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