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U.S. Department of Health and Human Services

Class 2 Device Recall The Polarus Plus Humeral Rod

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 Class 2 Device Recall The Polarus Plus Humeral Rodsee related information
Date Initiated by FirmMarch 07, 2012
Date PostedApril 02, 2012
Recall Status1 Terminated 3 on July 25, 2012
Recall NumberZ-1357-2012
Recall Event ID 61333
510(K)NumberK951740 
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
ProductThe 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***"
Code Information LOT 266220
FEI Number 1000125930
Recalling Firm/
Manufacturer		 Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro OR 97124-9432
For Additional Information ContactRichard F. Snyder
503-627-9957 Ext. 1302
Manufacturer Reason
for Recall		The packaging contains the wrong product. It does not contain model HR-0824-S as the package indicates.
FDA Determined
Cause 2		Labeling mix-ups
ActionAcumed 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 Commerce12 rods
DistributionWorldwide Distribution - USA (nationwide) and the countries of Italy, Ireland, and Great Britain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HSB
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