Device product

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.

Z-0109-2015

September 23, 2014

Class II

Product summary

Firm: Signal Medical Corporation
Event: Event 69418
Status: Terminated
Classification: Class II
Quantity: 12 devices
Official record key: device-enforcement:Z-0109-2015

Official wording

Reason: Incorrect dimension on four liners was detected

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.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Incorrect dimension on four liners was detected