Reported Sep 2, 2015 · Terminated
APEX INTERFACE Hemi 54X and Flared 56X, 3 Hole Acetabular Shells; Model: H5-12354, H5-11356. Product Usage: The Apex…
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 INTERFACE Hemi 54X and Flared 56X3 Hole Acetabular Shells
- Model
H5-12354H5-11356
- Product UsageThe Apex Interface Acetabular System is intended for use in combination with the Apex Modular Hip Stem in total hip replacement procedures
- Lot codes and dates
- H5-12354Lots - 20127 and 20167
- H5-11356Lot - 20097
- Amount recalled
- 112
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
Why it was recalled
The device may have improper screw hole placement due to inaccurate location of the index line.
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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