Supracondylar 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
FDA Recall Z-2791-2016 · Posted 2016-09-13
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeHSB
Date Initiated2016-06-30
Date Terminated2017-06-21
Product Quantity1 unit in total
Reason for Recall
Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.
Firm 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 [email protected] 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.
Root Cause
Labeling mix-ups
Distribution Pattern
US distribution to state of: CA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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