CLASS I Device recall · Reported 26 Sep 2018 · FDA Enforcement Report
Doro Lucent Transitional Member recalled by Pro-Med Instruments
Pro-Med Instruments is recalling Doro Lucent 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
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-2972-2018
- 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
- Reason category
- Lead & Heavy Metals
- 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.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
DORO LUCENT Transitional Member, REF 1101.026 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
Questions about this recall
Is Doro Lucent Transitional Member recalled?
Yes. Pro-Med Instruments recalled Doro Lucent Transitional Member on 5 Jul 2018. The recall is Class I and its status is Terminated. Recall number Z-2972-2018.
Why was it recalled?
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.
Which lots are affected?
Serial Numbers: 1704002 1704004 1704005 1704007 1704011 1704041 1704010 1704019 1704012 1704014 1704016 1704017 1704021 1704024 1704025 1704036 1704038 1704018 1704008 1704031 1704026 1704027 1704028 1704029 1704030 1704032 1704034 1704035 1704006 1704037 1704039
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 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Pro-Med Instruments
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | DORO¿ Easy-Connect Navigation Adaptor recalled by Pro-Med Instruments | Pro-Med Instruments | Other | Nationwide |
| Device | CLASS I | Doro Lucent Locking Transitional Member recalled by Pro-Med Instruments | Pro-Med Instruments | Lead & Heavy Metals | 7 states |
| Device | CLASS I | Doro Lucent Base Unit recalled by Pro-Med Instruments | Pro-Med Instruments | Lead & Heavy Metals | 7 states |
| Device | CLASS II | pmi, pro med instruments, DORO(R) Sterile Disposable Skull recalled | Pro-Med Instruments | Sterility | Nationwide |
Other Spinal Implants recalls
All 1,157| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Neuro; Neuro; Crani; Ortho Spine Pack; Bmhm Neuro Pack recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: ENT recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Halyard medical convenience kits labeled as: A-P PACK recalled | AVID Medical | Sterility | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Medline medical convenience kits, labeled as recalled | Medline Industries | Other | Nationwide |