Recall Z-1602-2010 ยท HWC Screw, Fixation, Bone
Acumed LLC
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.
| Date | May 14, 2010 (initiated May 19, 2009) |
| Status | Terminated |
| Reason | Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw |
| 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 Acum |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K942340 | CORTICAL BONE SCREW Acu Med, Inc., Dec 5, 1994 |