Z-0336-2012

10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model RBP1202. The product...

Name: Z-0336-2012 10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model RBP1202. The product...
Creator: Acute Innovations Llc
Published: 2011-02-28
License: https://open.fda.gov/license/

Acute Innovations, LLC / initiated 2011-02-28 / Terminated / root cause: manufacturing process

FDA source

Acute Innovations Llc began a recall of 10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model RBP1202. The product is labeled in parts: "***Ribloc Rib Fracture... on 2011-02-28. The reason FDA records is "RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0336-2012
Status: Terminated
Initiated: 2011-02-28
Posted: 2011-12-01
Terminated: 2011-12-06
Recalling firm: Acute Innovations, LLC
Product: 10mm x 2.7mm RibLoc Screw, a component of the RibLoc Rib Fracture Plating System, Model RBP1202. The product is labeled in parts: "***Ribloc Rib Fracture Plating System***MATERIAL: Titanium***Rx ONLY***NON STERILE***SCREW***ACUTE Innovations LLC 21421 NW Jacobson Road, Suite 700 Hillsboro, OR 97124 USA www.acuteinnovations.com*** MediMark Europe Sarl*** 11 rue Emile ZOLA BP 2332****38003 GRENOBLE CEDEX 2 FRANCE" The Acumed Rib Congruent Bone Plate System is indicated for use in providing fixation during fractures, fusions, and osteotomies for the rib. The Acumed Rib Congruent Bone Plate System includes plates and screws designed specifically for the rib.
Product code: HRS Plate, Fixation, Bone
Reason for recall: RibLoc screw from lot L1008007 was out of specification. It would not engage with the hex tip properly.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: 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.
Quantity in commerce: 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.
Product codes and lots: lot L1008007; Part # RBP1202

Product code HRS

K051410Class IIAcumed Rib Congrient Bone Plate SystemAcumed, LLC / cleared 2005-07-21

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)