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U.S. Department of Health and Human Services

Class 2 Device Recall 3.5mm X 32.5mm Cortical Screw

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 Class 2 Recall
3.5mm X 32.5mm Cortical Screw
see related information
Date Posted August 28, 2008
Recall Status1 Terminated on February 03, 2010
Recall Number Z-2155-2008
Recall Event ID 48468
Premarket Notification
510(K) Number
K942340 
Product Classification Screw, Fixation, Bone - Product Code HWC
Product 3.5mm X 32.5mm Cortical Screw used with the Polarus Humeral Fixation System,. Product labeled in part, "Polarus Humeral Fixation System& SIZE: 3.5mm X 32.5mm Cortical Screw... REF HCO3325-S... Acumed 5885 NW Cornelius Pass Road Hillsboro, OR 97124-9432 ". Polarus Humeral Fixation System, 3.5mm X 32.5mm Cortical Screw are packaged in a sterile inner package which are placed into an outer box. The cortical screws are used with the Polarus Locking Humeral Rod (Polarus Huemral Fixation System) for the multi-planar fixation. The screws are sold individually to support the Polarus Locking Humeral Rod systems in the field.
Code Information Lot: W24552; Expiration date: 2010-05
Recalling Firm/
Manufacturer
Acumed LLC
5885 NW Cornelius Pass Rd
Hillsboro, Oregon 97124-9370
For Additional Information Contact Mr. Richard Snyder
503-627-9957 Ext. 293
Manufacturer Reason
for Recall
Package of 3.5mm X 32.5mm cortical screw may contain 3.5mm X 22.5mm cortical screw.
FDA Determined
Cause 2
CHANGE CONTROL (GMP - GOOD MANUFACTURING PRACTICE): Process Change Control
Action The firm issued a Product Removal notification on 12-27-2005 to their customers. The notification was sent by either FAX or by e-mail. The Product Removal Notification informed their customers of the issue, asked them to remove the screws from inventory and return the screws to Acumed. A reminder notification, dated 1/20/08 was issued to customers identifying the product and the problem and requesting the product be returned.
Quantity in Commerce 112 pieces
Distribution Worldwide Distribution --- USA including states of CA, KY, FL, TX, OH, OR, NY, ID NJ, NE, LA, WI, UT, MO, MS, GA, AZ and countries of United Kingdom, Italy, Puerto Rico, Turkey, Spain, Japan, South Africa, and Belgium.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = HWC and Original Applicant = ACUMED, INC.
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