Signal Medical Corporation: Medical Device Recall in 2014 - (Recall #: Z-0109-2015)
Updated on March 25, 2026.
See the recall detail below. You can also see other recalls from the same firm in 2014.
Data Source: FDA.
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.
Product Classification:
Class II
Date Initiated: September 23, 2014
Date Posted: October 29, 2014
Recall Number: Z-0109-2015
Event ID: 69418
Reason for Recall:
Incorrect dimension on four liners was detected
Status: Terminated
Product Quantity: 12 devices
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
Distribution Pattern:
US Distribution in MO only.
Voluntary or Mandated:
Voluntary: Firm initiated