CLASS I Device recall · Reported 26 Sep 2018 · FDA Enforcement Report

Doro Lucent Locking Transitional Member recalled by Pro-Med Instruments

Pro-Med Instruments is recalling Doro Lucent Locking Transitional Member, distributed in 7 states. The recall was initiated on 5 Jul 2018 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesSerial Numbers: 1704002 1704004 1704005 1704007 1704011 1704041 1704010 1704012 1704019 1704037 1704014 1704016 1704017 1704021 1704024 1704025 1704036 1704038 1704018 1704008 1704034 1704026 1704027 1704028 1704029 1704030 1704032 1704035 1704006 1704037 1704039 1709014

Quantity recalled31 units

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2971-2018
FDA event ID: 80628
Recalling firm: Pro-Med Instruments, Freiburg Im Breisgau, N/A
Classification: Class I
Status: Terminated
Recall initiated: 5 Jul 2018
FDA classified: 17 Sep 2018
Reported: 26 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: E-Mail
Reason category: Device Malfunction
Device type: Spinal Implants

Timeline

5 Jul 2018	Recall initiated by company
17 Sep 2018	Classified by FDA	+74 days
26 Sep 2018	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.

Product as listed by the FDA

DORO LUCENT Locking Transitional Member, REF 1101.031 Component of headrest system used in open and percutaneous craniotomies and spinal surgeries

Where it was distributed

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

California Georgia Mississippi Ohio Tennessee Texas West Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Serial Numbers: 1704002 1704004 1704005 1704007 1704011 1704041 1704010 1704012 1704019 1704037 1704014 1704016 1704017 1704021 1704024 1704025 1704036 1704038 1704018 1704008 1704034 1704026 1704027 1704028 1704029 1704030 1704032 1704035 1704006 1704037 1704039 1709014

Where was it sold?

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

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 80628

This product is part of a recall event; the main page for the event is Doro Lucent Transitional Member recalled by Pro-Med Instruments.

Reported	Class	Recall	Company	Reason	Where
26 Sep 2018	CLASS I	Doro Lucent Transitional Member recalled by Pro-Med Instruments	Pro-Med Instruments	Device Malfunction	7 states
26 Sep 2018	CLASS I	Doro Lucent Base Unit recalled by Pro-Med Instruments	Pro-Med Instruments	Device Malfunction	7 states

More recalls from Pro-Med Instruments

All 5

Reported	Class	Recall	Company	Reason	Where
4 Jun 2025Device	CLASS II	DORO¿ Easy-Connect Navigation Adaptor recalled by Pro-Med Instruments	Pro-Med Instruments	Other	Nationwide
26 Sep 2018Device	CLASS I	Doro Lucent Base Unit recalled by Pro-Med Instruments	Pro-Med Instruments	Device Malfunction	7 states
26 Sep 2018Device	CLASS I	Doro Lucent Transitional Member recalled by Pro-Med Instruments	Pro-Med Instruments	Device Malfunction	7 states
13 Dec 2017Device	CLASS II	pmi, pro med instruments, DORO(R) Sterile Disposable Skull recalled	Pro-Med Instruments	Device Malfunction	Nationwide

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