FDAFDA · Food and drugs·Recall number Z-0109-2015
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.
Published October 29, 2014 · Recall initiated: September 23, 2014
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Incorrect dimension on four liners was detected
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Signal Medical Corporation
- Distributor
- US Distribution in MO only.
- Lot
- Catalog #: WB-1-1122, Size: 36x52x20, Serial # B13085 Catalog #. WB-1-1110 Size: 36x50x20, Serial # B13099 Catalog # WB-1-1110, Size: 36x50x20, Serial #: B13105 Catalog # WB-1-1110, Size: 36x50x20, Serial # B13106
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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