Z-1357-2012

The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for...

Name: Z-1357-2012 The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for...
Creator: Acumed LLC
Published: 2012-03-07
License: https://open.fda.gov/license/

Acumed LLC / initiated 2012-03-07 / Terminated / root cause: labeling and UDI

FDA source

Acumed LLC began a recall of The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal... on 2012-03-07. The reason FDA records is "The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-1357-2012
Status: Terminated
Initiated: 2012-03-07
Posted: 2012-04-02
Terminated: 2012-07-25
Recalling firm: Acumed LLC
Product: The Polarus Plus Humeral Rod (part number HR-0824-S) is intended as an intramedullary fixation device for humeral fractures. It is sealed in an internal sterile blister pack within a box that is labeled in part: "Polarus Humeral Fixation System Size: 8mm X 240mm Polarus Plus Humeral Rod***Titanium***REF HR-0824-S***LOT 266220***RX only***Manufactured or distributed by: ACUMED 5885 NW Cornelius Pass Road Hillsboro, OR 97124 USA***"
Product code: HSB Rod, Fixation, Intramedullary And Accessories
Reason for recall: The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Acumed sent an Urgent Notice Device Recall letter dated March 5, 2012, to all affected consignees. A follow-up notification letter was sent to the domestic customers on March 9, 2012. The letter identified the product, the problem, and the action to be taken by the consignee. The consignees were instructed to further notify their consignees about the recall and to cease use of and return the affected product. Consignees were requested to respond using the enclosed response form. The form should be faxed to 503-520-9618. For questions regarding this recall call 503-627-9957, ext. 1302.
Quantity in commerce: 12 rods
Distribution: Worldwide Distribution - USA (nationwide) and the countries of Italy, Ireland, and Great Britain.
Product codes and lots: LOT 266220

Product code HSB

K951740Class IIIntramedulary Fixation RodAcu Med, Inc. / cleared 1995-08-11

MDM coverage of this record lists here, newest first.

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)