Polarus(R) Humeral Fixation System, size: 3.5mm x 25.0mm Cortical Screw, QTY 1, Ref: HCO3250-S Acumed, LLC Hillsboro, OR
FDA device recall Z-1602-2010 · posted 2010-05-14 · Terminated
Recall details
- Recalling firm
- Acumed LLC
- Reason for recall
- Mix-up of parts - Product labeled cortical bone screw actually contains Acutract fixation screw
- Action taken
- 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 Acumed Customer Service at 1-888-627-9957 for any questions regarding this notification.
- Root cause
- Employee error
- Status
- Terminated
- Product code
- HWC
- Quantity affected
- 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
- Date initiated
- 2009-05-19
- Date posted
- 2010-05-14
- Date terminated
- 2010-05-17
- Location
- Hillsboro, OR
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| CORTICAL BONE SCREW (K942340) | Acu Med, Inc. | 1994-12-05 |