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Class 2 Device Recall Orthopedic implant |
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Date Initiated by Firm |
May 13, 2008 |
Date Posted |
December 11, 2008 |
Recall Status1 |
Terminated 3 on May 13, 2010 |
Recall Number |
Z-0447-2009 |
Recall Event ID |
48470 |
510(K)Number |
K992525
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Product Classification |
Prosthesis, shoulder, hemi-, humeral, metallic uncemented - Product Code HSD
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Product |
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 "
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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). |
Recalling Firm/ Manufacturer |
Acumed LLC 5885 NW Cornelius Pass Rd Hillsboro OR 97124-9370
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For Additional Information Contact |
Richard F. Snyder 503-627-9957 Ext. 1302
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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.
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FDA Determined Cause 2 |
Labeling mix-ups |
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 |
Quantity in Commerce |
20 units |
Distribution |
World-wide distribution including states of GA, MD, CA, MO, and AL, countries of United Kingdom, South Korea, South Africa, and Spain. |
Total Product Life Cycle |
TPLC Device Report
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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.
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510(K) Database |
510(K)s with Product Code = HSD and Original Applicant = ACUMED, INC.
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