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U.S. Department of Health and Human Services

Class 2 Device Recall Stryker T2 Supracondylar Nail System

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 Class 2 Device Recall Stryker T2 Supracondylar Nail Systemsee related information
Date Initiated by FirmJune 30, 2016
Date PostedSeptember 13, 2016
Recall Status1 Terminated 3 on June 21, 2017
Recall NumberZ-2791-2016
Recall Event ID 74727
510(K)NumberK023267 
Product Classification Rod, fixation, intramedullary and accessories - Product Code HSB
ProductSupracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended to provide strong and stable internal fixation with minimal soft tissue irritation of the distal femur. (1( Open and closed femoral fractures, (2) Pseudoarthrosis and correction osteotomy, (3) Pathologic fractures, impending pathologic fractures, and tumor resections, (4) Supracondylar fractures, including those with intra-articular extension, (5) Fractures distal to a Total Hip Prosthesis and (6) Non-unions and malunions
Code Information Catalog number 18220930S and Lot Code K836729
Recalling Firm/
Manufacturer		 Stryker Howmedica Osteonics Corp.
325 Corporate Dr
Mahwah NJ 07430-2006
For Additional Information ContactMr. 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
ActionThe 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 Commerce1 unit in total
DistributionUS distribution to state of: CA.
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = HSB
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