Copperhead IBFD, Large Neutral, 6mm Copperhead IBFD, Large Neutral, 7mm Copperhead IBFD, Large Neutral, 8mm Copperhead I
FDA device recall Z-1417-2013 · posted 2013-05-27 · Terminated
Recall details
- Recalling firm
- Spinal Solutions, LLC
- Reason for recall
- The recall of the Loaner Bin and Sterilization Trays for implants and instruments was initiated by Spinal Solutions because the directions for use and surgical techniques were not being provided to every physician and for every surgery.
- Action taken
- Spinal Solutions sent a recall letter dated March 8, 2013 to all customers who purchased loaner bins and sterilization trays for implants and instruments from Spinal Solutions. The letter identified the affected product, problem identified and actions to be taken. Customers are instructed to call the office at the number (951) 304-9001 if they are requesting paper copies of any of the literature.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- MAX
- Quantity affected
- 24 units
- Distribution
- USA Nationwide Distribution in the states of MS: TX, NV, CA, MD, and WI.
- Date initiated
- 2013-02-20
- Date posted
- 2013-05-27
- Date terminated
- 2014-03-26
- Location
- Murrieta, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| EMINENT SPINE INTERBODY FUSION SYSTEM (K090064) | Eminent Spine | 2009-04-09 |