Recall Z-2972-2018— Pro-Med Instruments Gmbh

Name: FDA recall Z-2972-2018
Creator: U.S. Food and Drug Administration
Published: 2018-07-05

Class I · Terminated

Class I FDA medical device recall by Pro-Med Instruments Gmbh, initiated 2018-07-05, terminated 2020-11-19. It names one FDA 510(k) clearance: K032331. Product: DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries. 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..

Recalling firm: Pro-Med Instruments Gmbh
Classification: Class I
Status: Terminated
Initiated: 2018-07-05
Terminated: 2020-11-19
Firm location: Freiburg Im Breisgau, N/A, Germany

510(k) clearances named in this recall

1 on FDA's record

K032331 — DORO RADIOLUCENT HEADREST SYSTEM AND HORSESHOE HEADRESTS,AND NON-RADIOLUCENT J-ARM RETRACTOR SYSTEM (ALUMINUM ALLOY)Pro-Med Instruments GmbH·cleared 2003-11-20

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

DORO LUCENT Transitional Member, REF 1101.026 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.