About the database
How to use the database
Download the data
FAQ
Credits
Manufacturers
Theken Spine LLC
Manufacturer Address
Theken Spine LLC, 283 E Waterloo Rd, Akron OH 44319-1238
Source
USFDA
1 Event
Recall of Torque Limiting Handle
{{ $t('card.reduce') }}
{{ $tc('card.more', left) }}
One device in the database
Torque Limiting Handle
Model / Serial
The Torque handles contain serial #1 through serial #76 and are part number 10-40-0122 contained in the Coral Lumbar System, Lot W1902 and W1558.
Product Classification
Orthopedic Devices
Device Class
1
Implanted device?
No
Distribution
The product was distributed to AL, AR, CA, FL, ID, IN, KS, LA, MO, NJ, OH, PA, TX, UT, WA, WV.
Product Description
Torque Limiting Handle, model # 10-40-0122, a component of the Lumbar Coral System (Pedicle Screw System).
2 manufacturers with a similar name
Learn more about the data
here
Theken Spine LLC
Manufacturer Address
Theken Spine LLC, 1800 Triplett Blvd, Akron OH 44306-3311
Manufacturer Parent Company (2017)
Theken Spine Llc
Source
USFDA
Theken Spine Llc
Manufacturer Address
Theken Spine Llc, 1800 Triplett Blvd, Akron OH 44306-3311
Manufacturer Parent Company (2017)
Theken Spine Llc
Source
USFDA
Language
English
Français
Español
한국어