Spinal Elements 5.5 x 45MM Mercury lordosed rod. A component of the Mercury Spinal System, comprised of a variety of scr
FDA device recall Z-1597-2015 · posted 2015-05-11 · Terminated
Recall details
- Recalling firm
- Spinal Elements, Inc
- Reason for recall
- Some rods may not meet the appropriate traceability requirements including the lot number. Some rods were found to not include the product identification number (product number and lot number) marked directly on the rod. The lack of marking interrupts the ability to maintain traceability of the device.
- Action taken
- The firm sent customer notification letters on 04/09/15. In this letter the firm requested that all affected lots be returned, and replacement inventory will be made available. The firm requested that customers take the following actions: 1. Immediately examine inventory for part number 60100-045. 2. Immediately discontinue the use and/or distribution of the affected lots 3. Send all affected product back to: Spinal Elements, Inc. ATTN: Julie Lamothe 3115 Melrose Drive Carlsbad, CA 92010 4. If further distributed the product to please identify the customers and notify them as once. 5. Complete and return the enclosed "Customer Response Form." Any questions the firm states to contact the Customer Service department at 1.877.SPINAL5 Ext. 213.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- NKB
- Quantity affected
- 588
- Distribution
- Nationwide Distribution including the states of GA, CA, TX, CO, IN, NC, FL, UT, TN, MO, MI, PA, OH, and OK.
- Date initiated
- 2015-04-09
- Date posted
- 2015-05-11
- Date terminated
- 2015-06-25
- Location
- Carlsbad, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| MERCURY SPINAL SYSTEM (K071914) | Spinal Elements, Inc. | 2007-10-12 |