Home / Recalls / Blue Belt Technologies MN / Z-1943-2014

Z-1943-2014 Class II Terminated

Recalled by Blue Belt Technologies MN — Plymouth, MN

Recall Details

Product Type
Devices
Report Date
July 9, 2014
Initiation Date
June 4, 2014
Termination Date
August 4, 2014
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
2

Product Description

Stride Femoral Component Size 2, PFSI-00054, Right Medial /Left Lateral. Unicondylar Knee prosthesis.

Reason for Recall

Mislabeled. Packages labeled PFSI-00053, Right Lateral/Left Medial contains PFSI-00054, Right Medial/Left lateral implants. Packages labeled PFSI-00054, Stride Right Medial/Left Lateral contain PFSI-00053, Left Medial/Right Lateral.

Distribution Pattern

US Nationwide Distribution in the states of CA, PA, and TX

Code Information

Lot C785241, Exp 4-2015

Other recalls by Blue Belt Technologies MN

  • Z-1942-2014 Class II — Stride Femoral Component Size 2, PFSI-00053, Right Lateral /Left Medial. Unicond (June 4, 2014)
  • Z-1575-2014 Class II — NavioPFSTM System, Orthopedic Sterotaxic Instrument, model #'s NPFS-02000, NPFS (April 11, 2014)
  • Z-1995-2013 Class II — Blue Belt Technologies, Inc. Monitor Drape REF: PFSD-V0001, Rx only, Sterile EO (July 19, 2013)