Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... P
FDA device recall Z-2153-2008 · posted 2008-08-28 · Terminated
Recall details
- Recalling firm
- Acumed LLC
- Reason for recall
- Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.
- Action taken
- The firm issued an Urgent Notification: Product Removal letter on 6-29-2007. The notification was reportedly sent by either FAX or e-mail. The notification informed consignees to remove the plates from their inventory and return them to Acumed. The notification did not include any instructions for a sub-recall. On 6/13/08, the firm sent a second Urgent Notification: Product Removal letter. This letter describes the product as PL-DR50L - Lot Code - W48003, explains the problem and asks customers to return product to Acumed.
- Root cause
- Process control
- Status
- Terminated
- Product code
- HRS
- Quantity affected
- 51 pieces
- Distribution
- Worldwide Distribution --- including USA and countries of South Africa, Italy, Finland, and Brazil.
- Date initiated
- 2007-06-29
- 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 |
|---|---|---|
| CONGRUENT BONE PLATE SYSTEM (K012655) | Acu Med, Inc. | 2001-11-07 |