Home / Recalls / Stryker Howmedica Osteonics Corp. / Z-2396-2016

Z-2396-2016 Class II Terminated

Recalled by Stryker Howmedica Osteonics Corp. — Mahwah, NJ

FDA device recall Z-2396-2016 was initiated by Stryker Howmedica Osteonics Corp. on July 1, 2016 and is designated Class II. Reason for recall: Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle. The recall status is terminated (terminated June 8, 2017). Affected quantity: 241 units.

Recall Details

Product Type
Devices
Report Date
August 17, 2016
Initiation Date
July 1, 2016
Termination Date
June 8, 2017
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
241 units

Product Description

Orthopedic manual surgical instrument Usage: Exeter Rasp Handle is a reusable instrument which is part of the Exeter femoral hip system. Exeter femoral rasps are assembled with the rasp handle and locked in place by closing down the lever on the rasp handle. The rasp handle is then used to guide the rasp into the patients femur and is impacted using a mallet in order to remove bone and further prepare the femur.

Reason for Recall

Malfunctioning of the Exeter Rasp/trial introducer/extractor Handle.

Distribution Pattern

Worldwide Distribution - US Nationwide

Code Information

Catalog No. 0930-9-003

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-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)
  • Z-2390-2016 Class II — Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary (June 23, 2016)

FDA data resources