Z-2155-2008

3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part...

Name: Z-2155-2008 3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part...
Creator: Acumed LLC
Published: 2005-12-27
License: https://open.fda.gov/license/

Acumed LLC / initiated 2005-12-27 / Terminated / root cause: packaging

FDA source

Acumed LLC began a recall of 3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm... on 2005-12-27. The reason FDA records is "Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-2155-2008
Status: Terminated
Initiated: 2005-12-27
Posted: 2008-08-28
Terminated: 2010-02-03
Recalling firm: Acumed LLC
Product: 3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 ". Polarus Humeral Fixation System, 3.5mm X 32.5mm Cortical Screw are packaged in a sterile inner package which are placed into an outer box. The cortical screws are used with the Polarus Locking Humeral Rod (Polarus Huemral Fixation System) for the multi-planar fixation. The screws are sold individually to support the Polarus Locking Humeral Rod systems in the field.
Product code: HWC Screw, Fixation, Bone
Reason for recall: Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw.
Root cause tag: packaging
FDA root cause: Process change control
Action: The firm issued a Product Removal notification on 12-27-2005 to their customers. The notification was sent by either FAX or by e-mail. The Product Removal Notification informed their customers of the issue, asked them to remove the screws from inventory and return the screws to Acumed. A reminder notification, dated 1/20/08 was issued to customers identifying the product and the problem and requesting the product be returned.
Quantity in commerce: 112 pieces
Distribution: Worldwide Distribution --- USA including states of CA, KY, FL, TX, OH, OR, NY, ID NJ, NE, LA, WI, UT, MO, MS, GA, AZ and countries of United Kingdom, Italy, Puerto Rico, Turkey, Spain, Japan, South Africa, and Belgium.
Product codes and lots: Lot: W24552; Expiration date: 2010-05

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)