Devices

Device Recall 27ga ONESTEP (tm) Endo Illuminator, Synergetics, inc.

Model / Serial
Lot number: M262090
Product Classification
Ophthalmic Devices
Device Class
2
Implanted device?
No
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Argentina, Austria, Brazil, Canada, China, Egypt, France, Germany, Greece, Hong Kong, Italy, Japan, Mexico, Morocco, the Netherlands, Pakistan, South Korea, Spain, Sweden, Switzerland, and the United Kingdom.
Product Description
27ga ONE-STEP (tm) Endo Illuminator, Synergetics, inc., length 7.5 ft, sterile / EO, 56.02.27P. Packed 12 units per box. Manufactured for Synergetics, Inc., O'Fallon, MO.
Manufacturer
Synergetics Inc
1 Event
- Recall of Device Recall 27ga ONESTEP (tm) Endo Illuminator, Synergetics, inc.

Manufacturer

Synergetics Inc

Manufacturer Address
Synergetics Inc, 3845 Corporate Centre Dr, O Fallon MO 63368-8678
Manufacturer Parent Company (2017)
Bausch Health Cos., Inc.
Source
USFDA

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