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Recall Observatory FDA recall evidence

Device product

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.

Z-0193-2018

November 02, 2017

Class II

Product summary

Firm
Pro-Med Instruments Gmbh
Event
Event 78501
Status
Terminated
Classification
Class II
Quantity
1142 units
Official record key
device-enforcement:Z-0193-2018

Official wording

Reason: 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.

Code information: Lots: 17041 and 17272

Distribution pattern: Worldwide Distribution - US (nationwide) Internationally to Germany, Saudi Arabia, France, United Kingdom, Australia, Austria, Ireland, South Africa, Hungary, India, Spain, Italy, Japan, and Canada

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.