Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
XTANT Medical Holdings, Inc · Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect be…
Open FDA's page for this record- Cfres ID
- 205344
- Product res number
- Z-0846-2024
- Event date initiated
- 2023-11-28
- Event date posted
- 2024-01-29
- Recall status
- Open, Classified
- Res event number
- 93738
- Product code
- NKB
- Product description
- Cortera Spinal Fixation System, REF: 150100-85050. Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length.
- Code info
- UDI-DI: 00810076564005, Lot: AP23000143
- Firm FEI number
- 3005031160
- Recalling firm
- XTANT Medical Holdings, Inc
- Address 1
- 664 Cruiser Ln
- City
- Belgrade
- State
- MT
- Postal code
- 59714-9719
- Additional info contact
- Michele Dolan 406-813-4145
- Root cause description
- Process control
- Action
- On 11/28/23 the recall notice was emailed. Customers with questions can call the firm at 1-406-924-5878 from 8 a.m. to 5 p.m. (Mountain Time).
- Product quantity
- 6
- Distribution pattern
- US distribution in MI.
- Reason for recall
Spinal fixation screws labeled as 8.5 mm diameter, 50 mm length were manufactured using an incorrect screw shank component, and so the labeling is incorrect because the affected screws are in fact 5.5 diameter, 45 mm length screws, which if used may lead to the screw not engaging.
- K numbers
- K221403
- Harmonized identifiers (openFDA)
- Device name
- Thoracolumbosacral Pedicle Screw System
- Medical specialty description
- Orthopedic
- Regulation number
- 888.3070
- Device class
- 2
- K number
- K180176, K231744, K163096, K141044, K101971, K180337, K211414, K052054, K203056, K111449, K183117, K222031, K060979, K051275, K223274, K182974, K090320, K100757, K221244, K091782, K111502, K190361, K173882, K201926, K060615, K073267, K113270, K032033, K231069, K070995, K071380, K151648, K170611, K170251, K190600, K073172, K150092, K121342, K221332, K112607 +875 more
- Registration number
- 3008534770, 2027467, 3008754074, 3007922509, 3006563559, 3031261833, 3011964577, 3007279845, 3041915189, 2648623, 3011277306, 3009971621, 3013548554, 3011500362, 9611274, 3010009693, 9615766, 3021006165, 3003639920, 1450662, 3009540749, 3015212339, 3009631939, 3006493760, 3004176895, 9610612, 2133928, 1000200989, 3024999441, 3008850074, 8020776, 1224360, 3007125392, 3004941535, 3015869121, 3021948057, 2133687, 3030412764, 3010863450, 1066368 +375 more
- FEI number
- 3008534770, 2027467, 3008754074, 3007922509, 3006563559, 1000115331, 3031261833, 3011964577, 3007279845, 3041915189, 3001814066, 1000306431, 2648623, 3011277306, 3009971621, 3008647423, 3013548554, 3011500362, 3010009693, 3021006165, 1000221916, 3003639920, 1450662, 3009540749, 3015212339, 3009631939, 3002287318, 3006493760, 3004176895, 3000206619, 1000200989, 3024999441, 3008850074, 3010938185, 3007125392, 3000717902, 3004941535, 3015869121, 3000717687, 3021948057 +375 more