Z-1602-2010

Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC...

Name: Z-1602-2010 Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC...
Creator: Acumed LLC
Published: 2009-05-19
License: https://open.fda.gov/license/

Acumed LLC / initiated 2009-05-19 / Terminated / root cause: manufacturing process

FDA source

Acumed LLC began a recall of Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR Intended use: Acumed intramedullary... on 2009-05-19. The reason FDA records is "Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw". 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-1602-2010
Status: Terminated
Initiated: 2009-05-19
Posted: 2010-05-14
Terminated: 2010-05-17
Recalling firm: Acumed LLC
Product: Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR Intended use: Acumed intramedullary rods and screws are designed to provide fixation of humeral, forearm and fibula fractures while they heal.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw
Root cause tag: manufacturing process
FDA root cause: Employee error
Action: On May 18, 2009, the firm, ACUMED, began calling customers. On May 19, 2009, the ACUMED sent e-mails and a "URGENT NOTICE: DEVICE RECALL" Initial Notice letter to all customers. The letter describes the product, problem and actions to be taken by customers. The customers were instructed to identify the product having the lot code(s) and quarantine them, return all products from the lot code(s) to Acumed immediately, to please notify the customers of this recall if you further distributed this product, and complete and return the Acumed Product Recall Effectiveness Form. Please contact Acumed Customer Service at 1-888-627-9957 for any questions regarding this notification.
Quantity in commerce: 83
Distribution: Worldwide distribution: USA including FL, GA, MI, MN, NY, TX, VA and countries of United Kingdom, Herzeles, South Korea, South Africa, China, and Milan
Product codes and lots: Lot code 203214

Product code HWC

K942340Class IICortical Bone ScrewAcu Med, Inc. / cleared 1994-12-05

China's FDA-registered implant bench is 151 establishments of 4,70415 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)