Devices

Device Recall Calix T PEEK Lumbar System

Model / Serial
Size, 28mm x 10mm x 6mm, Part #:, X034-0360, Lot #:, 23515, 23516, 24295, 24836, 24836s1, 24836S2, 657001, 760913 & Size, 28mm x 10mm x 10mm, Part #:, X034-0364, Lot #:, 23517, 23518, 24296, 24837, 657002, 760914.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV. Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.
Product Description
Calix T PEEK Lumbar System, TLIF Rasp
Manufacturer
X Spine Systems Inc
1 Event
- Recall of Device Recall Calix T PEEK Lumbar System

Manufacturer

X Spine Systems Inc

Manufacturer Address
X Spine Systems Inc, 452 Alexandersville Rd, Miamisburg OH 45342-3658
Manufacturer Parent Company (2017)
X-Spine Systems, Inc
Source
USFDA

One device with a similar name

Learn more about the data here

Device Recall Calix T PEEK Lumbar System

Model / Serial
Size, 28mm x 10mm x 6mm, Part #:, X034-0340, Lot #:, 118501, 23502, 23503, 24284, 24291, 24825, 24825s1, 24825S2, 760902; Size, 28mm x 10mm x 7mm, Part #:, X034-0341, Lot #:, 118502, 23504, 24285, 24826, 24826S1, 24826S2, 760903; Size, 28mm x 10mm x 8mm, Part #:, X034-0342, Lot #:, 118503, 23505, 24286, 24827, 24827S1, 24827S2, 760904; Size, 28mm x 10mm x 9mm, Part #:, X034-0343, Lot #:, 118504, 23506, 24287, 24828, 24828S1, 24828S2, 760905; Size, 28mm x 10mm x 10mm, Part #:, X034-0344, Lot #:, 118505, 23507, 24288, 24829, 24829S1, 24829S2, 760906; Size, 28mm x 10mm x 11mm, Part #:, X034-0345, Lot #:, 118506, 23508, 24289, 24830, 24830S1, 24830S2, 760907; Size, 28mm x 10mm x 12mm, Part #:, X034-0346, Lot #:, 118507, 23509, 24290, 24831, 24831S1, 24831s2, 760908; Size, 28mm x 10mm x 13mm, Part #:, X034-0347, Lot #:, 118508, 23510, 24291, 24832, 24832s1, 24832S2, 760909; Size, 28mm x 10mm x 14mm, Part #:, X034-0348, Lot #:, 118509, 23511, 24292, 24833, 760910; Size, 28mm x 10mm x 15mm, Part #:, X034-0349, Lot #:, 118510, 23512, 24293, 24293-R, 24834, 760911 & Size, 28mm x 10mm x 16mm, Part #:, X034-0350, Lot #:, 118511, 23513, 23514, 24294, 24835, 24835S1, 24835S2, 32513, 760912.
Product Classification
Orthopedic Devices
Device Class
2
Implanted device?
Yes
Distribution
Product was shipped to the following states: AZ, CA, CO, FL, GA, ID, IN, KY, LA, MD, MI, MO, NC, NV, NY, PA, PR, TX & WV. Product was also shipped to the following countries: Australia, England, Germany, Italy, Mexico, Portugal & United Kingdom.
Product Description
Calix T PEEK Lumbar System, TLIF Trial
Manufacturer
X Spine Systems Inc

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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