Recall Z-0109-2015 ยท LPH Prosthesis, Hip, Semi-Constrained, Metal/Polymer, Porous Uncemented
Signal Medical Corporation
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.
| Date | Oct 22, 2014 (initiated Sep 23, 2014) |
| Status | Terminated |
| Reason | Incorrect dimension on four liners was detected |
| Root cause | Process design |
| Action | Signal Medical Corporation verbally notified the only consignee via telephone. Please call Signal Medical Corp. at 1-800-246-6324 with any questions. |
| Quantity | 12 devices |
| Distribution | US Distribution in MO only. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K955271 | MICRO-SEAL ACETABULAR SYSTEM Whiteside Instruments, Jan 30, 1996 |