Z-2153-2008

Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate...

Name: Z-2153-2008 Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate...
Creator: Acumed LLC
Published: 2007-06-29
License: https://open.fda.gov/license/

Acumed LLC / initiated 2007-06-29 / Terminated / root cause: manufacturing process

FDA source

Acumed LLC began a recall of Acu-Loc Distal Radius Plate, Standard, Left. Product labeled in part, " Acu-Loc Distal Radius Plate, Standard, Left... PL-DR50L W48003... Manufactured or... on 2007-06-29. The reason FDA records is "Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-2153-2008
Status: Terminated
Initiated: 2007-06-29
Posted: 2008-08-28
Terminated: 2010-02-03
Recalling firm: Acumed LLC
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 ".
Product code: HRS Plate, Fixation, Bone
Reason for recall: Plates are incorrectly laser marked. The PL-DR50L plates are incorrectly laser marked with PL-DR70L.
Root cause tag: manufacturing process
FDA root cause: Process control
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.
Quantity in commerce: 51 pieces
Distribution: Worldwide Distribution --- including USA and countries of South Africa, Italy, Finland, and Brazil.
Product codes and lots: Lot: W4800; Expiration date: 2012-02

Product code HRS

K012655Class IICongruent Bone Plate SystemAcu Med, Inc. / cleared 2001-11-07

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)