Recall Z-1664-2013— SpineFrontier, Inc.
Class II · Terminated
Class II FDA medical device recall by SpineFrontier, Inc., initiated 2013-05-17, terminated 2016-05-17. It names one FDA 510(k) clearance: K092815. Product: BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.. Reason: The S-LIFT Instrument Case contained a bracket with peeling nylon coating..
- Recalling firm
- SpineFrontier, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-05-17
- Terminated
- 2016-05-17
- Firm location
- Beverly, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
BASE, S-LIFT Instrument Case Product Usage: System cases are designed to hold and secure all instrumentation to be used with a surgical system. Case and caddy components are used to contain implants intended for intervertebral body fusion and fixation of the spine.
Reason for recall
The S-LIFT Instrument Case contained a bracket with peeling nylon coating.
Data sourced from openFDA. This site is unofficial and independent of the FDA.