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U.S. Department of Health and Human Services

Class 2 Device Recall Exeter Rasp/Trial Introducer/Extractor Handle part of the Exeter Femoral Hip System

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  Class 2 Device Recall Exeter Rasp/Trial Introducer/Extractor Handle part of the Exeter Femoral Hip System see related information
Date Initiated by Firm July 01, 2016
Date Posted August 11, 2016
Recall Status1 Terminated 3 on June 08, 2017
Recall Number Z-2396-2016
Recall Event ID 74743
510(K)Number K110290  
Product Classification Prosthesis, hip, semi-constrained, metal/polymer, cemented - Product Code JDI
Product Orthopedic manual surgical instrument

Usage:
Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.
Code Information Catalog No. 0930-9-003
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information Contact Mr. Michael Van Ryn
201-831-5838
Manufacturer Reason
for Recall		 Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.
FDA Determined
Cause 2		 Device Design
Action Stryker notified Branches/Agencies of the Urgent Medical Device Recall by e-mail on July 1, 2016 and an "Urgent Medical Device Recall Letter and Business Reply Form" was sent to branches, agents and hospital risk management via UPS (with return receipt) on July 5, 2016. The letter identified then affected product, problem and actions to be taken. For questions call (201) 831-6693.
Quantity in Commerce 241 units
Distribution Worldwide Distribution - US Nationwide
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 = JDI and Original Applicant = HOWMEDICA OSTEONICS CORP
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