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 "
This recall has been terminated (originally issued December 11, 2008).
- Company
- Acumed Llc
- Recall Initiated
- May 13, 2008
- Posted
- December 11, 2008
- Terminated
- May 13, 2010
- Recall Number
- Z-0447-2009
- Quantity
- 20 units
- Firm Location
- Hillsboro, OR
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
World-wide distribution including states of GA, MD, CA, MO, and AL, countries of United Kingdom, South Korea, South Africa, and Spain.
Lot / Code Info
Modular Shoulder Body Assembly, 15mm, Left: Part number: SH-1540L-S ; Work order number/Lot: W51097 (W=work order, ###=sequential number); Expiration date: 2012-06 (Year/Month) Modular Shoulder Body Assembly, 15mm, Right : Part number: SH-1540R-S ; Work order number/Lot: W51098 (W=work order, ###=sequential number); Expiration date: 2012-06 (Year/Month).
Root Cause
Labeling mix-ups
Action Taken
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