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U.S. Department of Health and Human Services

Class 2 Device Recall Flat Proximal Pressurizer.

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  Class 2 Device Recall Flat Proximal Pressurizer. see related information
Date Initiated by Firm January 13, 2012
Date Posted March 12, 2012
Recall Status1 Terminated 3 on July 24, 2013
Recall Number Z-1198-2012
Recall Event ID 60892
Product Classification Dispenser, cement - Product Code KIH
Product Flat Proximal Pressurizer.

Bone cement pressurizers are intended to help seal the delivery path between the delivery nozzle and bone in order to pressurize the cement during delivery.
Code Information Part Number: 0206-556-000; Lot: 11271012
Recalling Firm/
Manufacturer
Stryker Instruments Div. of Stryker Corporation
4100 E Milham Ave
Portage MI 49002-9704
For Additional Information Contact
269-323-7700
Manufacturer Reason
for Recall
The firm identified two complaints have been reported indicating that the product inside the package did not match with the label information. The product was labeled as Flat Proximal Pressurizer P/N 0206-556-000 while the product inside the package was Femoral Pressurizer P/N 0206-566-000.
FDA Determined
Cause 2
Mixed-up of materials/components
Action Stryker Instruments sent an "Urgent Medical Device Recall notification" dated January 13, 2012, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed to : Immediately check all stock areas or operating room storage and quarantine any affected product found. Mark product as RECALLED PRODUCT. Please indicate on the BRF the quantity of affected Pressurizers you are returning and fill in the form completely. Sign the BRF (even if you do not have any affected product). Note: Your signature on the BRF indicates that you received and understand this notification and are returning all affected product from your facility. Fax the Business Reply Form to Stryker Instruments Regulatory Department, 866-521-2762. Upon receipt of the BRF, Stryker will contact you to coordinate the return of all affected product that you have on hand. Send back all affected product using the pre-paid shipper provided to you by Stryker. Upon receipt of the product, a replacement will be issued to your account
Quantity in Commerce 10 boxes (60 units)
Distribution Worldwide Distribution -- Nationwide, including the states of AL and OK and the country of Canada.
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.
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