Home / Recalls / Stryker Howmedica Osteonics Corp. / Z-2792-2016

Z-2792-2016 Class II Terminated

Recalled by Stryker Howmedica Osteonics Corp. — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
September 21, 2016
Initiation Date
June 30, 2016
Termination Date
June 21, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit in total

Product Description

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

Reason for Recall

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

Distribution Pattern

US distribution to state of: CA.

Code Information

Catalog number 18251032S and Lot Code K288335

Other recalls by Stryker Howmedica Osteonics Corp.

  • Z-2160-2017 Class II — Hoffmann LRF Safety Clip (Bone Transport Strut), 14 x 12 x 5 mm, REF 4933-0-401, (April 26, 2017)
  • Z-1020-2017 Class II — Reunion TSA Peg Alignment Sound Catalog #5901-1038 The Peg Alignment Sound (P (December 2, 2016)
  • Z-0880-2017 Class II — GAM Kirschner Wire, Sterile R, T2 K-Wire, Sterile R and T2 K-Wire Recon, Stryker (November 9, 2016)
  • Z-0378-2017 Class II — LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF (August 29, 2016)
  • Z-0060-2017 Class II — Stryker Orthopaedics Universal Acetabular Cup Positioner/Impactor, REF 2101-0200 (August 18, 2016)
  • Z-2789-2016 Class II — Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, ND (August 1, 2016)
  • Z-2396-2016 Class II — Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusabl (July 1, 2016)
  • Z-2791-2016 Class II — Supracondylar Nail T2 SCN 09x300 mm T2 Supracondylar Nail System is intended (June 30, 2016)
  • Z-2377-2016 Class II — Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541 (June 23, 2016)
  • Z-2390-2016 Class II — Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary (June 23, 2016)