Freiburg Im Breisgau, N/A, Germany

Pro-Med Instruments Gmbh recalls

2 recalls recorded since 2018, most recently on 14 March 2025. 1 is listed as ongoing. Status and classification are as published by the FDA.

Recalls2

Ongoing (FDA)1

Terminated or completed1

Class I (FDA)1

Recall started: 14 March 2025
Reason: 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.
Distribution: 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,
Initiated: Voluntary: Firm initiated
Recall number: Z-1860-2025

Recall started: 5 July 2018
Terminated: 19 November 2020
Reason: The combination of two different design revisions of DORO LUCENT Base Unit, Locking Transitional Member, and Transitional Member within one set up might lead to a malfunction and failure of the headrest system.
Distribution: Worldwide distribution to US states of CA, TX, TN, MS, GA, WV, and OH, Qatar, India, UK, Singapore, Australia, Germany, South Africa, Italy, and Japan
Initiated: Voluntary: Firm initiated
Recall numbers: Z-2972-2018, Z-2970-2018, Z-2971-2018

DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries
DORO LUCENT Base Unit, REF 1101.021 Headrest System used in open and percutaneous craniotomies and spinal surgeries
DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.