Microseal Augmented — Class II medical device recall Z-0109-2015
Terminated recall by Signal Medical Corporation, reported 2014-10-29. Incorrect dimension on four liners was detected
| Recall number | Z-0109-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Signal Medical Corporation, Marysville, MI, United States |
| Recall initiated | 2014-09-23 |
| Classified | 2014-10-21 |
| Reported by FDA | 2014-10-29 |
| Terminated | 2015-01-20 |
| Quantity | 12 devices |
| Serial numbers | B13085, B13099, B13105, B13106 |
| Model numbers | WB-1-1110, WB-1-1122 |
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 for recall
Incorrect dimension on four liners was detected
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0109-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.