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U.S. Department of Health and Human Services

Class 2 Device Recall 3'" Titanium Skull Pin

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  Class 2 Device Recall 3'" Titanium Skull Pin see related information
Date Initiated by Firm September 26, 2008
Date Posted January 02, 2009
Recall Status1 Terminated 3 on April 27, 2010
Recall Number Z-0594-2009
Recall Event ID 50111
510(K)Number K023959  K040363  
Product Classification Fixation Accessory - Product Code LYT
Product Ossur 3'" Titanium Skull Pin, 1 pack, Model Number: 516V2S
Code Information Lot Number: 08060410
Recalling Firm/
Manufacturer
Ossur
Grjothals 5
Reykjavik Ireland
Manufacturer Reason
for Recall
Ossur has initiated this voluntary recall as a precautionary measure because the firm is unable to guarantee the sterility of the affected products.
FDA Determined
Cause 2
Packaging process control
Action Ossur initiated contact with the customers to locate the pins on Sept. 26, 2008 with the Product Manager for this device contacting each consignee by phone. The customers were informed the recall was initiated because the firm was unable to guarantee the sterility of the affected products. Customers were asked to check their inventory for the affected parts. If products were located, they were informed that an Ossur customer service representative will be emailing you with return information any they are to return these pins to the firm as soon as possible. They were also told Ossur does not currently have replacement product available, but they will contact them immediately when they are available. If the products were not located, they were asked to determine where these pins are currently located, if they have been applied to a patient? If so, are they able to track down that patient and bring them in for an evaluation?
Quantity in Commerce 27 pouches (1 pin/per pouch) = 27 pins
Distribution Nationwide Distribution --- including states of FL, KS, MI, MO, NY, & WA.
Total Product Life Cycle TPLC 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) Database 510(K)s with Product Code = LYT and Original Applicant = THE JEROME GROUP, INC.
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