—#148301

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

FDA product code: HSB — Rod, Fixation, Intramedullary And Accessories
Device class: Class 2
Medical specialty: Orthopedic
510(k) numbers: K010801
Affected lot / code info: Catalog number 18251032S and Lot Code K288335

Why it was recalled

Stryker discovered that a Tibial Nail and femoral Nail were incorrectly labeled and distributed to the field.

Root cause (FDA determination)

Labeling mix-ups

Action the firm took

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.

Recalling firm

Firm: Stryker Howmedica Osteonics Corp.
Address: 325 Corporate Dr, Mahwah, New Jersey 07430-2006

Distribution

Distribution pattern: US distribution to state of: CA.

Timeline

Recall initiated: 2016-06-30
Posted by FDA: 2016-09-13
Terminated: 2017-06-21
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #148301. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.