The ACUTE Innovations Modular RibLoc System (RibLoc U plus) is comprised titanium plates and screws that are used to sta
FDA device recall Z-0852-2014 · posted 2014-01-28 · Terminated
Recall details
- Recalling firm
- ACUTE Innovations, LLC
- Reason for recall
- The ACUTE Innovations Ribloc U plus Rib Fracture Plating System is recalled because it has the potential to malfunction during installation in a surgery.
- Action taken
- The firm sent the Urgent Notice: Device Recall letter, dated 30 Oct. 2013, to their consignees. The recall notification letter requested consignees to return the product to Acute and a return authorization number provided. Consignees should contact Acute Innovations Customer Service at 866-623-4137 for any questions regarding this recall notification.
- Root cause
- Under Investigation by firm
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 176 units
- Distribution
- US Distribution in states of Arizona, Georgia, Illinois, Indiana, Utah, and Wisconsin.
- Date initiated
- 2013-10-30
- Date posted
- 2014-01-28
- Date terminated
- 2014-03-13
- Location
- Hillsboro, OR
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUTE INNOVATIONS MODULAR RIBLOC SYSTEM (K113318) | Acute Innovations, LLC | 2012-01-12 |