FDAFDA · Food and drugs·Recall number Z-0193-2018
pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box), STERILE R, Rx ONLY The DORO(R) Skull Pins are inserted into the receptacles of the skull clamp and fixate the head during surgery.
Published December 13, 2017 · Recall initiated: November 2, 2017
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
The firm received reports of two breakages of the pin tips which occurred during two identical surgery procedures. The breakage occurred at the very distal end of the conical part of the skull pin tip.
What to do
Voluntary: Firm initiated · E-Mail
Recall details
- Manufacturer
- Pro-Med Instruments Gmbh
- Distributor
- Worldwide Distribution - US (nationwide) Internationally to Germany, Saudi Arabia, France, United Kingdom, Australia, Austria, Ireland, South Africa, Hungary, India, Spain, Italy, Japan, and Canada
- Lot
- Lots: 17041 and 17272
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- Germany
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