Nakoma-SL Anterior Cervical Plating System's Variable Single Barrel Drill Guide Product Usage: The Nakoma-SL ACP System
FDA device recall Z-1989-2015 · posted 2015-07-07 · Terminated
Recall details
- Recalling firm
- Alliance Partners LLC
- Reason for recall
- Inadequate interference between the screw and the plate when screw implanted into the plate at angulation greater than 7 degrees can result in the screw advancing through the plate during implantation.
- Action taken
- Alliance Spine sent an Urgent Medical Device Field Action Notification letter dated June 15, 2015 to all affected customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to complete the response form and fax to 210-314-2524.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- KWQ
- Quantity affected
- 21 units
- Distribution
- US Nationwide Distribution in the states LA, TX, and PR.
- Date initiated
- 2015-06-09
- Date posted
- 2015-07-07
- Date terminated
- 2015-10-09
- Location
- San Antonio, TX
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAKOMA ACP (K141993) | Alliance Partners, LLC | 2014-11-06 |