FDA Recall
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
·
Initiated September 23, 2014
Recall
- Recall Number
- Z-0109-2015
- Event Number
- 69418
- Firm
- Signal Medical Corporation
- FEI Number
- 3002477077
- Product Code
- LPH
- Status
- Terminated
- Root Cause
- Process design
- Initiated
- September 23, 2014
- Posted
- October 22, 2014
- Terminated
- January 20, 2015
- Address
- 400 Pyramid Dr, Marysville, MI, 48040-2463
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
Action
Signal Medical Corporation verbally notified the only consignee via telephone. Please call Signal Medical Corp. at 1-800-246-6324 with any questions.
Distribution
US Distribution in MO only.
Quantity
12 devices