ENDURAMESH CORPECTOMY SPACER SYSTEM 013MM, 017MM, 023MM by varying heights. Dist. By: Lucero Medical, PO Box 67, Richfie
FDA device recall Z-1059-2012 · posted 2012-02-17 · Terminated
Recall details
- Recalling firm
- Lucero Medical LLC
- Reason for recall
- During an FDA inspection the firm was informed that the device marketed is not the device cleared for the 510K associated with the device. The product is sold unlabeled.
- Action taken
- Lucero Medical LLC made a personal visit to facilities in regards to an Urgent Medical Device Recall as of January 12, 2012. The firm instructed the customer that they were removing and quarantining all product from the facility. If you have any further questions, please contact Lucero Medical, PO Box 69, Richfield, Ohio 44826, Director of Quality Assurance/Natalie Williams/ (440) 670-9583
- Root cause
- Device Design
- Status
- Terminated
- Product code
- MQP
- Quantity affected
- 190 units
- Distribution
- USA Nationwide Distribution - in the state of OH.
- Date initiated
- 2012-01-11
- Date posted
- 2012-02-17
- Date terminated
- 2014-04-11
- Location
- Hinckley, OH
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