Reported Jul 22, 2015 · Terminated
Apex ARC Hip Stem, HA Coated, Size 5; Product Code: HC-21005-HA Product Usage: The Apex ARC Hip Stem is the femoral…
Omnilife Science 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: Omnilife Science Inc. · 50 Oconnell Way Ste 10 · East Taunton, MA · 02718-1394
Is this the product you have?
- Apex ARC Hip Stem, HA Coated, Size 5
- Product CodeHC-21005-HA
- Product UsageThe Apex ARC Hip Stem is the femoral component of a primary or revision total hip replacement. This femoral hip stem is intended for press-fit application and is provided sterile for single use. They are manufactured from titanium alloy. The stem has a proximal porous coating of titanium plasma spray under a coating of hydroxyapatite (HA)
- Lot codes and dates
- Lot Numbers
567957777420758877878369860588699485968818070
- Lot Numbers
- Amount recalled
- 146 devices
Where it was sold
Why it was recalled
Product may breach the inner and outer sterile pouches during shipping or handling.
This product could cause temporary or reversible health problems — stop using it.
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