Acumed LLC Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ". Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or Distributed by: Acumed LLC Hillsboro, OR ".
Brand
Acumed LLC
Lot Codes / Batch Numbers
Lot: W4800, Expiration date: 2012-02
Products Sold
Lot: W4800; Expiration date: 2012-02
Acumed LLC is recalling Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, due to Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026