Mercury Spinal System DIA 5.5 x 400mm Straight Rod, Part Number: 60101-400. Intended to provide immobilization and stabi
FDA device recall Z-1266-2013 · posted 2013-05-07 · Terminated
Recall details
- Recalling firm
- Spinal Elements, Inc
- Reason for recall
- Spinal Elements has initiated a recall for the Mercury Spinal System due to a raw material issue.
- Action taken
- Spinal Elements sent Urgent Medical Device Recall notification letters to all affected customers. The letter identified the product, problem, and actions to be taken by the customers. Contact the Chief Technology Officer at Spinal Elements for questions about the recall letter.
- Root cause
- Nonconforming Material/Component
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 68 units total
- Distribution
- Distributed in OH and PA.
- Date initiated
- 2009-04-17
- Date posted
- 2013-05-07
- Date terminated
- 2013-05-07
- Location
- Carlsbad, CA
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MERCURY SPINAL SYSTEM (K071914) | Spinal Elements, Inc. | 2007-10-12 |