Pro-Med Instruments Gmbh recalls pmi, pro med instruments, DORO(R) Sterile Disposable Skull Pins, 3 pieces (3 pieces per blister, 12 blisters per box),…

Recall date

November 2, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0193-2018

FDA classification

Class II

Brand / firm

Pro-Med Instruments Gmbh

Sold / distributed

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

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.