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 ".
FDA Recall Z-2153-2008 · Posted 2008-08-28
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Recalling FirmAcumed LLC
Recall StatusTerminated
Product CodeHRS
Date Initiated2007-06-29
Date Terminated2010-02-03
Product Quantity51 pieces
Reason for Recall
Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.
Firm Action
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
Distribution Pattern
Worldwide Distribution --- including USA and countries of South Africa, Italy, Finland, and Brazil.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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