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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker T2 Femoral Nail System

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  Class 2 Device Recall Stryker T2 Femoral Nail System see related information
Date Initiated by Firm June 30, 2016
Date Posted September 13, 2016
Recall Status1 Terminated 3 on June 21, 2017
Recall Number Z-2792-2016
Recall Event ID 74727
510(K)Number K010801  
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
Product Femoral Nail, A/R T2 Femur 011x280 mm

T2 Femoral Nailing System is one of the first femoral nailing systems to offer an option for either an antegrade or a retrograde approach to repair fractures of the femur. (1) Open and closed femoral fractures, (2) Pseudoarthrosis and correction, (3) osteotomy, (4) Pathologic fractures, impending pathologic fractures, and tumor resections, (5) Supracondylar fractures, including those with intra-articular extension, (6) Ipsilateral femur fractures, (7) Fractures proximal to a total knee arthroplasty, (8) Fractures distal to a hip joint and (9) Non-unions and malunions
Code Information Catalog number 18251032S and Lot Code K288335
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		 Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
FDA Determined
Cause 2		 Labeling mix-ups
Action The firm, Stryker, sent an "URGENT MEDICAL DEVICE RECALL" letter dated June 30, 2016 by e-mail to its customer requesting that they quarantine affected devices and sent the letter via UPS (with return receipt) on July 1, 2016. The letter described the product, problem and actions to be taken. The customer was instructed to inform users of the Medical Device Removal and forward the notice to all who need to be aware; inspect your inventory and return affected products to Stryker Orthopaedics/PFA Product Returns, Attn: Distribution Inventory Team; 325 Corporate Drive; Dock M-East , Mahwah, NJ 07431 REF: PFA #2016-094; complete and return the Business Reply Form via email to SO_M_PRODUCT_FIELD_ACTION_RESPONSE@stryker.com within 5 days; and keep a copy of the completed and executed Business Reply Form for your records. If you have any questions, feel free to contact the Mgr., Divisional Regulatory Compliance, Marketing Quality at (201) 831-6693.
Quantity in Commerce 1 unit in total
Distribution US distribution to state of: CA.
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 = HSB and Original Applicant = HOWMEDICA OSTEONICS CORP.
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