FDAFDA · Food and drugs·Recall number Z-0092-2015
DePuy Synthes Radiolucent Retractor, part number 387.580, lot number 3620715
Published October 29, 2014 · Recall initiated: October 2, 2014
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
Particle residue on the instrument from adhesive tape which was used to bind the device during transport. There may be a risk of tissue reaction if a patient is exposed to latex particles from the adhesive tape, or a systemic reaction such as anaphylaxis in patients with latex allergy.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Synthes, Inc.
- Distributor
- US Distribution including the states of PA, NC, TN, NY, WI, WA and MI.
- Lot
- Radiolucent Retractor for Upper Cervical Spine part number 387.580, lot number 3620715.
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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