Enduramesh Corpectomy Spacer System Product Usage: The Enduramesh is a vertebral body replacement system intended for us
FDA device recall Z-2368-2012 · posted 2012-09-11 · Terminated
Recall details
- Recalling firm
- Lucero Medical LLC
- Reason for recall
- The firm voluntarily recalled the device after they discovered that the sterilization recommendations on the product insert did not pass sterilization validation.
- Action taken
- Lucero Medical sent a Field Correction Notice letter dated July 15, 2012 to it's sole consignee. The notice identified the affected product., problem and actions to be taken. The customer was instructed to complete the response card and submit back to their local Lucero Medical Representative.
- Root cause
- Error in labeling
- Status
- Terminated
- Product code
- MQP
- Quantity affected
- 169
- Distribution
- US Nationwide Distribution
- Date initiated
- 2012-07-15
- Date posted
- 2012-09-11
- Date terminated
- 2013-02-20
- Location
- Independence, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENDURAMESH, MODEL 762.XXX (K093207) | Lucero Medical, LLC | 2010-04-26 |