Home / Recalls / Stryker Howmedica Osteonics Corp. / Z-0378-2017

Z-0378-2017 Class II Terminated

Recalled by Stryker Howmedica Osteonics Corp. — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
November 16, 2016
Initiation Date
August 29, 2016
Termination Date
May 2, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
42,519 units (total Catalog numbers)

Product Description

LFIT Anatomic V40 Femoral Head, Low Friction Ion Treatment, Sterile, 36 mm, REF 6260-9-236; Modular components designed to be locked onto a femoral hip stem trunnion during surgery for total hip replacement.

Reason for Recall

Stryker received several complaints describing incidence of harm secondary to taper lock failure for specific lots of numerous catalog numbers of LFIT Anatomic CoCr V40 Femoral Heads.

Distribution Pattern

US Nationwide and Internationally

Code Information

Catalog #6260-9-236 - Head Diameter 36 mm, Offset +5, including all lots manufactured from 1/102 - 7/1/10; Catalog #6260-9-240 - Head Diameter 40 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-244 - Head Diameter 44 mm, Offset +4, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-340 - Head Diameter 40 mm, Offset +8, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-440 - Head Diameter 40 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11; Catalog #6260-9-344 - Head Diameter 44 mm, Offset +8, including all lots manufactured from 1/1/07 - 3/4/11 and Catalog #6260-9-444 - Head Diameter 44 mm, Offset +12, including all lots manufactured from 1/1/06 - 3/4/11.

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-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-2792-2016 Class II — Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the (June 30, 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)