Spine Frontier Inspan compressors Part Number: 11-60004. Inspan compressors provide pressure to drive spikes of Inspan i
FDA device recall Z-0412-2013 · posted 2012-11-21 · Terminated
Recall details
- Recalling firm
- SpineFrontier, Inc.
- Reason for recall
- Inspan Compressors may break at weld causing a loss of compression
- Action taken
- Spine Frontier issued e-mail notices to customers on May 14, 2012 advising of the potential for breakage. Units were replaced with weld free design.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWP
- Quantity affected
- 17 units
- Distribution
- Worldwide Distribution-USA (nationwide) including PR and the states of FL, MA, MO, OK, and TX, and the country of Mexico.
- Date initiated
- 2012-08-28
- Date posted
- 2012-11-21
- Date terminated
- 2015-06-11
- Location
- Beverly, MA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| PARADIGM INTERSPINOUS FUSION PLATE (K093438) | Paradigm Spine, LLC | 2010-10-06 |