FDA Enforcement
Class II
Terminated
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.
Recall: Z-0109-2015
·
Reported October 29, 2014
Enforcement
- Recall Number
- Z-0109-2015
- Event ID
- 69418
- Classification
- Class II
- Status
- Terminated
- Product Type
- Devices
- Firm
- Signal Medical Corporation
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Telephone
- Report Date
- October 29, 2014
- Initiation Date
- September 23, 2014
- Classification Date
- October 21, 2014
- Termination Date
- January 20, 2015
- Address
- 400 Pyramid Dr, Marysville, MI, 48040-2463, United States
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
Incorrect dimension on four liners was detected
Code Info
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
US Distribution in MO only.
Quantity
12 devices