Reported Oct 29, 2014 · Terminated
Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes…
Signal Medical Corporation
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: Signal Medical Corporation · 400 Pyramid Dr · Marysville, MI · 48040-2463
Is this the product you have?
- Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x20; and 36x50x20. Device is intended for use with Whiteside Biomechanics, Inc./Signal Medical Corporation Micro-Seal Shell in an uncemented Total Hip Replacement.
- Lot codes and dates
- Catalog #: WB-1-1122
- Size
36x52x20Serial # B13085 Catalog #
- WB-1-1110 Size
36x50x20Serial # B13099 Catalog # WB-1-1110
- Size
36x50x20Serial #: B13105 Catalog # WB-1-1110
- Size
36x50x20Serial # B13106
- Amount recalled
- 12 devices
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
Why it was recalled
Incorrect dimension on four liners was detected
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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