Home / Recalls / Stryker Howmedica Osteonics Corp. / Z-2281-2016

Z-2281-2016 Class II Terminated

Recalled by Stryker Howmedica Osteonics Corp. — Mahwah, NJ

Recall Details

Product Type
Devices
Report Date
August 3, 2016
Initiation Date
June 3, 2016
Termination Date
August 1, 2018
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1,864 units

Product Description

Stryker Orthopaedics Trident Constrained Liner Inserter/Impactor Tip, 22 mm, 28 mm, and 32 mm. Non Sterile Catalog Numbers 2199-2022, 2199-2028 and 2199-2032. For use in total hip arthroplasty.

Reason for Recall

Impactors do not meet the required sterility assurance level (SAL) of 10-6 when using the recommended steam sterilization method.

Distribution Pattern

Worldwide distribution. US nationwide (AL, AR, AZ, CA, CO, CT, FL, GA, IA, IL, IN, KS, KY, LA, MA, MD, MI, MN, MS, NJ, NY, OH, PA, TX, WA, WI, WV), Sweden, South Africa, Chile, Australia, New Zealand, Canada, United Kingdom, Switzerland, Colombia, and Poland.

Code Information

Catalog Nos. 2199-2022, 2199-2028 and 2199-2032 All lots manufactured from May 30, 2012

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-2792-2016 Class II — Femoral Nail, A/R T2 Femur 011x280 mm T2 Femoral Nailing System is one of the (June 30, 2016)
  • Z-2377-2016 Class II — Stryker Orthopaedics Modular Handle Triathlon Instruments, Non-Sterile, REF 6541 (June 23, 2016)