Microseal Augmented (20 degrees) Liner, acetabular liner component made from UHMW polyethylene (ASTM F648). Sizes 36x52x
FDA device recall Z-0109-2015 · posted 2014-10-22 · Terminated
Recall details
- Recalling firm
- Signal Medical Corporation
- Reason for recall
- Incorrect dimension on four liners was detected
- Action taken
- Signal Medical Corporation verbally notified the only consignee via telephone. Please call Signal Medical Corp. at 1-800-246-6324 with any questions.
- Root cause
- Process design
- Status
- Terminated
- Product code
- LPH
- Quantity affected
- 12 devices
- Distribution
- US Distribution in MO only.
- Date initiated
- 2014-09-23
- Date posted
- 2014-10-22
- Date terminated
- 2015-01-20
- Location
- Marysville, MI
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MICRO-SEAL ACETABULAR SYSTEM (K955271) | Whiteside Instruments | 1996-01-30 |