3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral
FDA device recall Z-2155-2008 · posted 2008-08-28 · Terminated
Recall details
- Recalling firm
- Acumed LLC
- Reason for recall
- Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw.
- Action taken
- 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.
- Root cause
- Process change control
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 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 Af
- Date initiated
- 2005-12-27
- Date posted
- 2008-08-28
- Date terminated
- 2010-02-03
- Location
- Hillsboro, OR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORTICAL BONE SCREW (K942340) | Acu Med, Inc. | 1994-12-05 |