FDAFDA · Food and drugs·Recall number Z-3262-2018
HipLOC Hip Fracture Fixation System-Hiploc System 135¿ Plate 38 mm Barrel 3 Hole Plate Item Number: 2110-135-003 Product Usage: The HipLOC Compression Hip Screw may be used primarily for fixation of bone fractures. Specific indications include open reduction and internal fixation of a wide variety of fractures of the proximal femur: intracapsular fractures, intertrochanteric fractures and subtrochanteric fractures
Published October 3, 2018 · Recall initiated: August 9, 2018
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
HipLOC System Plate Barrel due to an undersized bore on the HipLOC plate barrel, can result in the lag screw not fitting through the barrel
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Manufacturer
- Biomet UK Ltd.
- Distributor
- US Nationwide in the states of AZ, MO, NJ and NM
- Lot
- Lot Number: 3680822 3680823 3680824 3680825 3700273
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United Kingdom
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