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Devices
Device Recall StaXx IB Convex Expandable Implant
Model / Serial
Lot Numbers: 272L08 and 272L09
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Distributed in the states of FL and OR.
Product Description
StaXx¿ IB Convex Expandable Implant (25 x 12 x 9 mm), Intervertebral Fusion Device, Lumbar; Catalog Number 11 -1902. || Indicated for intervertebral body fusion procedures in skeletally mature patients.
Manufacturer
Spine Wave, Inc.
1 Event
Recall of Device Recall StaXx IB Convex Expandable Implant
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Manufacturer
Spine Wave, Inc.
Manufacturer Address
Spine Wave, Inc., 3 Enterprise Dr Ste 302, Shelton CT 06484-4694
Manufacturer Parent Company (2017)
Spine Wave Inc
Source
USFDA
Language
English
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