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Z-0109-2015 Class II Terminated

Recalled by Signal Medical Corporation — Marysville, MI

Recall Details

Product Type: Devices
Report Date: October 29, 2014
Initiation Date: September 23, 2014
Termination Date: January 20, 2015
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 12 devices

Product Description

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.

Reason for Recall

Incorrect dimension on four liners was detected

Distribution Pattern

US Distribution in MO only.

Code Information

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