Recall Z-2155-2008 ยท HWC Screw, Fixation, Bone
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.
| Date | Aug 28, 2008 (initiated Dec 27, 2005) |
| Status | Terminated |
| Reason | Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw. |
| 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 | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942340 | CORTICAL BONE SCREW Acu Med, Inc., Dec 5, 1994 |