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U.S. Department of Health and Human Services

Class 2 Device Recall Orthopedic implant

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 Class 2 Device Recall Orthopedic implantsee related information
Date Initiated by FirmMay 13, 2008
Date PostedDecember 11, 2008
Recall Status1 Terminated 3 on May 13, 2010
Recall NumberZ-0447-2009
Recall Event ID 48470
510(K)NumberK992525 
Product Classification Prosthesis, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
ProductModular 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 "
Code Information 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).  
FEI Number 1000125930
Recalling Firm/
Manufacturer		 Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro OR 97124-9370
For Additional Information ContactRichard F. Snyder
503-627-9957 Ext. 1302
Manufacturer 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.
FDA Determined
Cause 2		Labeling mix-ups
ActionThe 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
Quantity in Commerce20 units
DistributionWorld-wide distribution including states of GA, MD, CA, MO, and AL, countries of United Kingdom, South Korea, South Africa, and Spain.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HSD
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