10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model RBP1202. The product is labeled
FDA device recall Z-0336-2012 · posted 2011-12-01 · Terminated
Recall details
- Recalling firm
- Acute Innovations Llc
- Reason for recall
- RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly.
- Action taken
- The firm, ACUTE Innovation, sent an "URGENT NOTICE: DEVICE RECALL" letter dated February 21, 2011, to all consignees/customers via FED-EX on February 28, 2011. The letter describes the product, problem and actions to be taken. The customers were instructed to identify product having the lot code(s) and quarantine them; return all product from this lot to Acute Innovations immediately using shipping labels provided or return to: Acute Innovations, LLC, 21421 NW Jacobson Rd, Suite 700, Hillsboro, OR, 97124, and if they further distributed this product, notify those customers of this recall and request return of product(s). Customers can call ACUTE Innovation at 1-866-623-4137 for any questions about this recall.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 299 units (267 in US and 32 to South Africa)
- Distribution
- Worldwide distribution: USA (nationwide) including states of: AL, AR, AZ, CA, GA, IL, MN, NC, NY, UT, and WA; and countries of: South Africa.
- Date initiated
- 2011-02-28
- Date posted
- 2011-12-01
- Date terminated
- 2011-12-06
- Location
- Hillsboro, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ACUMED RIB CONGRIENT BONE PLATE SYSTEM (K051410) | Acumed, LLC | 2005-07-21 |