FDA Recall Terminated

Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labeled in part, "Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 "

Recall: Z-0447-2009 · Initiated May 13, 2008

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Recall

Recall Number
Z-0447-2009
Event Number
48470
Firm
Acumed LLC
FEI Number
1000125930
Product Code
HSD
Status
Terminated
Root Cause
Labeling mix-ups
Initiated
May 13, 2008
Posted
December 11, 2008
Terminated
May 13, 2010
Address
5885 NW Cornelius Pass Rd, Hillsboro, OR, 97124-9370

Description

Modular Shoulder Body Assembly, Left (SH-1540L-S) and Modular Shoulder Body Assembly, Right (SH-1540R-S). Product labeled in part, "Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 "

Reason

The packages for Modular Shoulder Body Assembly Left (SH-1540L-S) and Modular Shoulder Body Assembly Right (SH-1540R-S) may contain assemblies for the opposite side as indicated.

Action

The firm issued a Urgent Notice: Device Recall on 5/13/08. The firm notified consignees of the issue and asked them to return the product to Acumed with the enclosed product recall effectiveness form for customers. For further information contact Acumed customer service at 1-888-627-9957

Distribution

World-wide distribution including states of GA, MD, CA, MO, and AL, countries of United Kingdom, South Korea, South Africa, and Spain.

Quantity

20 units