FDA Device recall Z-0109-2015
Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648)
- FDA Device
- Class II
- terminated
- Published 2014-10-29
On 2014-10-29 the FDA classified a Class II recall of Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648) by Signal Medical, citing incorrect dimension on four liners was detected.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0109-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2014-09-23 |
| Published | 2014-10-29 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Signal Medical |
| Distribution | MO |
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.
Reason
Incorrect dimension on four liners was detected
Identifiers
| code_info | Catalog #: WB-1-1122, Size: 36x52x20, Serial # B13085 Catalog #. WB-1-1110 Size: 36x50x20, Serial # B13099 Catalo…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0109-2015%22
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