Acumed LLC 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) Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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)
Brand
Acumed LLC
Lot Codes / Batch Numbers
Lot: W24552, Expiration date: 2010-05
Products Sold
Lot: W24552; Expiration date: 2010-05
Acumed LLC is recalling 3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in pa due to Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
AZ, CA, FL, GA, ID, KY, LA, MS, MO, NE, NJ, NY, OH, OR, TX, UT, WI, PR
Page updated: Jan 10, 2026