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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker

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 Class 2 Recall
Stryker
see related information
Date Posted July 31, 2013
Recall Status1 Terminated on October 14, 2014
Recall Number Z-1846-2013
Recall Event ID 65646
Premarket Notification
510(K) Number
K043431 
Product Classification Rod, Fixation, Intramedullary And Accessories - Product Code HSB
Product GAMMA3 System Long Nail Kit, R2.0, Ti, Left Distributed in USA by Howmedica Osteonics Corp., 325 Corporate Drive, Mahwah, NJ 07430 USA A single use device intended for the temporary fixation, correction of stabilization of the right femur. The kit consists of intramedullary nail and set screw. The kit is used in combination with lag screw and (distal) locking screws and end cap as well.
Code Information Catalog Number- 33250400S Catalog Number 33250360S
Recalling Firm/
Manufacturer
Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah, New Jersey 07430-2002
For Additional Information Contact Ms. Colleen O'Meara
201-972-2100
Manufacturer Reason
for Recall
Stryker Osteosynthesis has become aware that LEFT GAMMA3 nails are marked as right nails.
FDA Determined
Cause 2
PRODUCTION CONTROLS: Process Control
Action Stryker sent notification letters and product accountability forms dated May 21, 2013. via Fed Ex with return receipt to all branches/agencies and on May 22, 2013, via Fed Ex with return receipt to all hospital risk management, chief of orthoapedics, and surgeons. Our records indicate that you may have received and/or used the above referenced product(s). It is Stryker's®® responsibility as the manufacturer to ensure that customers who may have received and/or used these affected products also receive this important communication. Please contact your Stryker®® Sales Representative to arrange for return of the product if you have any of the above listed items. Please assist us in meeting our regulatory obligation by faxing back the attached Product Recall Acknowledgment Form as soon as possible to 855- 251-3635. Please note that your signature on the following form only confirms that you received this notification and does not obligate you to take any additional action beyond what is called for in this notification letter. We regret any inconvenience this action may cause you and if you have any questions, please call (201) 972-2100.
Quantity in Commerce 5 units
Distribution US Distribution including the states of IL, KY and TN.
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 = HSB and Original Applicant = HOWMEDICA OSTEONICS CORP.
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