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 ".
This recall has been terminated (originally issued August 28, 2008).
- Company
- Acumed Llc
- Recall Initiated
- June 29, 2007
- Posted
- August 28, 2008
- Terminated
- February 3, 2010
- Recall Number
- Z-2153-2008
- Quantity
- 51 pieces
- Firm Location
- Hillsboro, OR
- Official Source
- View on FDA website ↗
Reason for Recall
Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.
Distribution
Worldwide Distribution --- including USA and countries of South Africa, Italy, Finland, and Brazil.
Lot / Code Info
Lot: W4800; Expiration date: 2012-02
Root Cause
Process control
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.