CLASS II Device recall · Reported 5 Apr 2017 · FDA Enforcement Report
The Stryker Visum¿ LED Surgical Lighting system recalled
Stryker Communications is recalling The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative, distributed nationwide in the US. The recall was initiated on 28 Feb 2017 and the FDA has classified it as Class II.
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-1699-2017
- FDA event ID
- 76633
- Recalling firm
- Stryker Communications, Flower Mound, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Feb 2017
- FDA classified
- 29 Mar 2017
- Reported
- 5 Apr 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Surgical Instruments
Timeline
| 28 Feb 2017 | Recall initiated by company | |
| 29 Mar 2017 | Classified by FDA | +29 days |
| 5 Apr 2017 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall.
Product as listed by the FDA
The Stryker Visum¿ LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light. Affected part numbers are 0682001432 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/FP), 0682001286 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/FP), 0682001298 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P), 0682001299 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 5P/5P), 0682001300 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/5P/5P), 0682001433 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P), 0682001434 (EDS LIGHT SUSPENSION, CENTRAL AXIS, 9P/5P), 0682001435 (EDS LIGHT SUSPENSION, CENTRAL AXIS, FP/9P/5P) Product Usage: The Stryker Visum LED Surgical Lighting system is intended to illuminate the operative site during surgical procedures with high intensity light
Where it was distributed
Worldwide distribution - United States Nationwide - Australia, Canada, Great Britain, Japan, Netherlands and Puerto Rico
Questions about this recall
Why was it recalled?
The potential hazard that can arise for the combination of the missing screws and the overloading by the end user is insufficient mount force that causes the equipment to fall.
Which lots are affected?
"Serial Numbers: 100000000098399 100000000099187 100000000099193 100000000093937 100000000094391 100000000093936 100000000087555 100000000091032 100000000093938 100000000093928 100000000093939 100000000098397 100000000092672 100000000093927 100000000106675 100000000106685 100000000109560 100000000109569 100000000109570 100000000086360 100000000089194 100000000091766 100000000091778 100000000098401 100000000099325 100000000103228 100000000090520 100000000102434 100000000102439 100000000103111 100000000088303 100000000089467 100000000094993 100000000095927 100000000101580 100000000092699 100000000101590 100000000101591 100000000103686 100000000109291 100000000097048 100000000112633 100000000087549 100000000094982 100000000091762 100000000112607 100000000112609 100000000091531 100000000106681 100000000106682 100000000106684 100000000106159 100000000091728 100000000103271 100000000090522 100000000099356 100000000089970 100000000090530
Where was it sold?
Worldwide distribution - United States Nationwide - Australia, Canada, Great Britain, Japan, Netherlands and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
More recalls from Stryker Communications
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|---|---|---|---|---|---|
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