Pro-Med Instruments Gmbh: Device Recall

Recall #Z-1860-2025 · 03/14/2025

Class II: Risk

Recall Details

Recall Number: Z-1860-2025
Classification: Class II
Product Type: Device
Recalling Firm: Pro-Med Instruments Gmbh
Status: Ongoing
Date Initiated: 03/14/2025
Location: Freiburg Im Breisgau, N/A, Germany
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 217 units

Reason for Recall

Potential of compromised compatibility resulting in influence on the positioning of the reference array and an influence of the function of the navigation system cannot be excluded.

Product Description

DORO¿ Easy-Connect Navigation Adaptor; BRAINLAB (item No. 1204.002)

Distribution Pattern

Worldwide - US Nationwide distribution in the states of CA, CO, KY, ID, IL, MA, MO, NC, NJ, NY, TX and the countries of Algeria, Argentina, Australia, Austria, Brazil, Burma, China, Colombia, Cyprus, Czech Republic, Ecuador, Egypt, France, Germany, Hungary, Indonesia, Ireland, Israel, Italy, Japan, Kazakhstan, Mexico, Mongolia, Netherlands, Norway, Philippines, Poland, Qatar, Russia, Russia, Singapore, Slovakia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Turkey, Ukraine, United Kingdom.

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.