Intervertebral Fusion Device With Bone Graft, Lumbar

Reports per year

Source: FDA adverse event reports by year received, 2012–2026. Reporting paused during the 2026 MAUDE-to-AEMS transition and has since resumed.

Recent recalls

• 2026-01-09Open, ClassifiedUnder Investigation by firm

  Medicrea, IB3D Universal Implant Inserter, Rx Only REF: A24000000

  Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

• 2026-01-09Open, ClassifiedUnder Investigation by firm

  Medicrea, IB3D PL Instruments Set, Rx Only REF: SPS03174

  Due to complaints, orthopedic rotation tool handle may untread from the shaft resulting in the inability to rotate implant.

• 2025-12-11Open, ClassifiedDevice Design

  Brand Name: FORZA" PTC Spacer System Product Name: FORZA" PTC Spacer System Model/Catalog Number: 38-1007SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 7H 38-1008SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 8H; 38-1009SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 9H; 38-1010SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 10H; 38-1011SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 11H; 38-1012SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 12H; 38-1013SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 13H; 38-1014SP FORZA PTC Spacer, Straight, 0, 9W x 23L x 14H; 38-1707SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 7H; 38-1708SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 8H; 38-1709SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 9H; 38-1710SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 10H; 38-1711SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 11H; 38-1712SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 12H; 38-1713SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 13H; 38-1714SP FORZA PTC Spacer, Curved, 0, 9W x 27L x 14H; 38-1807SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 7H; 38-1808SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 8H; 38-1809SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 9H; 38-1810SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 10H; 38-1811SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 11H; 38-1812SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 12H; 38-1813SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 13H; 38-1814SP FORZA PTC Spacer, Curved, 0, 11W x 27L x 14H; 38-3007SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 7H; 38-3008SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 8H; 38-3009SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 9H; 38-3010SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 10H; 38-3011SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 11H; 38-3012SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 12H; 38-3013SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 13H; 38-3014SP FORZA PTC Spacer, Straight, 0, 9W x 27L x 14H; 38-4007SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 7H; 38-4008SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 8H; 38-4009SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 9H; 38-4010SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 10H; 38-4011SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 11H; 38-4012SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 12H; 38-4013SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 13H; 38-4014SP FORZA PTC Spacer, Straight, 0, 11W x 27L x 14H; 38-4207SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 7H; 38-4208SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 8H; 38-4209SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 9H; 38-4210SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 10H; 38-4211SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 11H; 38-4212SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 12H; 38-4213SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 13H; 38-4214SP FORZA PTC Spacer, Curved, 0, 11W x 31L x 14H; 38-4508SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 8H; 38-4509SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 9H; 38-4510SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 10H; 38-4511SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 11H; 38-4512SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 12H; 38-4513SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 13H; 38-4514SP FORZA PTC Spacer, Curved, 8, 9W x 27L x 14H; 38-6007SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 7H; 38-6008SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 8H; 38-6009SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 9H; 38-6010SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 10H; 38-6011SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 11H; 38-6012SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 12H; 38-6013SP FORZA PTC Spacer, Straight, 0, 11W x 31L x 13H; 38-6014SP FORZA PTC Spacer,

  Labeling contains claims that are not consistently present.

• 2025-12-11Open, ClassifiedDevice Design

  Brand Name: Forza" Ti Spacer System Product Name: Forza" Ti Spacer System Model/Catalog Number: 38-2006SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 6H; 38-2007SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 7H; 38-2008SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 8H; 38-2009SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 9H; 38-2010SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 10H; 38-2011SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 11H; 38-2012SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 12H; 38-2013SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 13H; 38-2014SP FORZA Ti Spacer, Straight, 0, 9W x 23L x 14H; 38-2106SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 6H; 38-2107SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 7H; 38-2108SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 8H; 38-2109SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 9H; 38-2110SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 10H; 38-2111SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 11H; 38-2112SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 12H; 38-2113SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 13H; 38-2114SP FORZA Ti Spacer, Straight, 0, 9W x 27L x 14H; 38-2206SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 6H; 38-2207SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 7H; 38-2208SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 8H; 38-2209SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 9H; 38-2210SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 10H; 38-2211SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 11H; 38-2212SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 12H; 38-2213SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 13H; 38-2214SP FORZA Ti Spacer, Straight, 0, 11W x 27L x 14H; 38-2309SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 9H; 38-2310SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 10H; 38-2311SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 11H; 38-2312SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 12H; 38-2313SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 13H; 38-2314SP FORZA Ti Spacer, Straight, 8, 11W x 27L x 14H; 38-2508SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 8H; 38-2509SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 9H; 38-2510SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 10H; 38-2511SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 11H; 38-2512SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 12H; 38-2513SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 13H; 38-2514SP FORZA Ti Spacer, Straight, 8, 9W x 23L x 14H; 38-3206SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 6H; 38-3207SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 7H; 38-3208SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 8H; 38-3209SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 9H; 38-3210SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 10H; 38-3211SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 11H; 38-3212SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 12H; 38-3213SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 13H; 38-3214SP FORZA Ti Spacer, Straight, 0, 11W x 31L x 14H; 38-3409SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 9H; 38-3410SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 10H; 38-3411SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 11H; 38-3412SP FORZA Ti Spacer, Straight, 8, 11W x 31L x 12H;

  Labeling contains claims that are not consistently present.

• 2025-11-21Open, ClassifiedLabeling design

  Catalyft PL & PL40 Expandable Interbody System labeled as follows with corresponding model numbers: 1. SPACER 6068073 CATALYFT PL SHORT 7MM. Model Number: 6068073. 2. SPACER 6068076 CATALYFT PL LONG 7MM, Model Number: 6068076. 3. SPACER 6068093 CATALYFT PL SHORT 9MM, Model Number: 6068093. 4. SPACER 6068096 CATALYFT PL LONG 9MM, Model Number: 6068096. 5. SPACER 6068113 CATALYFT PL SHORT 11MM, Model Number: 6068113. 6. SPACER 6068116 CATALYFT PL LONG 11MM, Model Number: 6068116. 7. SPACER 6069073 CATALYFT PL40 SHORT 7MM, Model Number: 6069073. 8. SPACER 6069076 CATALYFT PL40 LONG 7MM, Model Number: 6069076. 9. SPACER 6069093 CATALYFT PL40 SHORT 9MM, Model Number: 6069093. 10. SPACER 6069096 CATALYFT PL40 LONG 9MM, Model Number: 6069096. 11. SPACER 6069113 CATALYFT PL40 SHORT 11MM, Model Number: 6069113. 12. SPACER 6069116 CATALYFT PL40 LONG 11MM, Model Number: 6069116. 13. CATALYFT PL IMPLANT SET, Model Number: SPS03143. 14. CATALYFT PL 40 IMPLANT SET, Model Number: SPS03144. 15. KIT CATALYFT PL IMPLANTS, Model Number: SPS04012. 16. KIT CATALYFT PL 40 IMPLANTS, Model Number: SPS04013. 17. CATALYFT PL 40 IMP KIT, Model Number: SPSJEP40. 18. CATALYFT PL 40 HIGH IMP KIT, Model Number: SPSJEP4H. 19. CATALYFT PL 40 SHORT IMP KIT, Model Number: SPSJEP4S. 20. CATALYFT PL 40 SHORT HIGH IMP KIT, Model Number: SPSJEP4T. 21. CATALYFT PL STRAIGHT HIGH IMP KIT, Model Number: SPSJEPSH. 22. CATALYFT PL STRAIGHT IMP KIT, Model Number: SPSJEPSI. These systems utilize the following affected Instructions for Use (IFU), Document M333023W048E, and Surgical Technique Guide, Document M333023W217.

  Expandable interbody system cage may loose height or collapse (loss of lordosis), which could result in migration, subsidence and/or neurological injury. Therefore, surgical technique and instructions for use will be updated to mitigate risk of loss of lordosis to occur.

• 2025-09-11Open, ClassifiedDevice Design

  Reef TA Inserter, Part Number: TA2-001003, part of the Reef Interbody System

  Inserter, used as part of a system with an intervertebral body fusion device, may contribute to difficulty disengaging the implant or improper implant positioning, which may may lead to prolonged surgery, intraoperative revision, and may require the use of alternate instrumentation. Devices may also have incorrect UDI-DI marking.

• 2025-09-11Open, ClassifiedLabeling design

  PILLAR SA Ti, STERILE, 37mm (W) x 28mm (D) x 18mm (H), 20-degrees, REF: 82-3713SP

  A 37 mm implant width intervertebral body fusion device has a labeling discrepancy with incorrect width of 33 mm stated on the outer label side flap and inner label side flap information box. The 37 mm width on the front labels is correct.

• 2025-03-21Open, ClassifiedLabeling Change Control

  Orthofix Pillar SA Ti Spacer System Intervertebral Body Fusion Spinal Device, sterile, implant grade titanium alloy: (1) REF 82-3300SP, 33mm W x 24mm D x 10mm H, 7 degrees; (2) REF 82-3700SP, 37mm W x 28mm D x 10mm H, 7 degrees; and (3) REF 82-4000SP, 40mm W x 32mm D x 10mm H, 7 degrees.

  The product is mislabeled with the incorrect anterior height of 10mm, but the laser marking on the implant and corresponding trial both show the correct anterior height of 10.5mm.

• 2025-01-30Open, ClassifiedUnder Investigation by firm

  Calibrate CCX Interbody System for spinal fusion procedures: Implants: (1) Calibrate CCX-O, 7 x 10 x 25mm 5 degrees, Part #325-07102505, nonsterile; (2) Calibrate CCX-O, 7 x 10 x 25mm 10 degrees, Part #325-07102510, nonsterile; (3) Calibrate CCX-O, 7 x 10 x 25mm 15 degrees, Part #325-07102515, nonsterile; (4) Calibrate CCX-O, 7 X 10 X 30mm 5 degrees, Part #325-07103005, nonsterile; (5) Calibrate CCX-O, 7 x 10 x 30mm 10 degrees, Part #325-07103010, nonsterile; (6) Calibrate CCX-O, 7 x 10 x 30mm 15 degrees, Part #325-07103015, nonsterile; (7) Calibrate CCX-O, 7 x 10 x 35mm 10 degrees, Part #325-07103510, nonsterile; (8) Calibrate CCX-O, 7 x 10 x 35mm 15 degrees, Part #325-07103515, nonsterile; (9) Calibrate CCX-O, 9 x 10 x 25mm 5 degrees, Part #325-09102505, nonsterile; (10) Calibrate CCX-O, 9 x 10 x 25mm 10 degrees, Part #325-09102510, nonsterile; (11) Calibrate CCX-O, 9 x 10 x 30mm 5 degrees, Part #325-09103005, nonsterile; (12) Calibrate CCX-O, 9 x 10 x 30mm 10 degrees, Part #325-09103010, nonsterile; (13) Calibrate CCX-O, 11 x 10 x 30mm 10 degrees, Part #325-11103010, nonsterile; (14) Calibrate CCX-S, 7 x 10 x 22mm 5 degrees, Part #326-07102205, nonsterile; (15) Calibrate CCX-S, 7 x 10 x 22mm 10 degrees, Part #326-07102210, nonsterile; (16) Calibrate CCX-S, 7 x 10 x 22mm 15 degrees, Part #326-07102215, nonsterile; (17) Calibrate CCX-S, 7 x 10 x 26mm 5 degrees, Part #326-07102605, nonsterile; (18) Calibrate CCX-S, 7 x 10 x 26mm 10 degrees, Part #326-07102610, nonsterile; (19) Calibrate CCX-S, 7 x 10 x 26mm 15 degrees, Part #326-07102615, nonsterile; (20) Calibrate CCX-S, 7 x 10 x 30mm 10 degrees, Part #326-07103010, nonsterile; (21) Calibrate CCX-S, 9 x 10 x 22mm 5 degrees, Part #326-09102205, nonsterile; (22) Calibrate CCX-S, 9 x 10 x 22mm 10 degrees, Part #326-09102210, nonsterile; (23) Calibrate CCX-S, 9 x 10 x 26mm 5 degrees, Part #326-09102605, nonsterile; (24) Calibrate CCX-S, 9 x 10 x 26mm 10 degrees, Part #326-09102610, nonsterile; and (25) Calibrate CCX-S, 11 x 10 x 26mm 10 degrees, Part #326-11102610, nonsterile. Convenience kits containing affected implants: (1) Calibrate CCX Oblique Implants, REF CLCCXOIMPA, containing 24 implants/kit, nonsterile; and (2) Calibrate CCX Straight Implants, REF CLCCXSIMPA, containing 36 implants/kit, nonsterile.

  Complaints have been received regarding post-operative implant collapse.

• 2024-09-17Open, ClassifiedDevice Design

  TxHA PEEK IBF/TxTiHA IBF System REF BTA-151 i. TxHA The Innovasis TxHA PEEK IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain. Users of these products are limited to physicians trained in orthopedic surgery. Clinical locations include hospitals and surgery sites equipped to perform spinal surgery. ii. TxTiHA The Innovasis TxTiHA IBF System is an intervertebral body fusion device intended to stabilize a spinal segment to promote fusion using bone graft, in order to restrict motion and decrease pain.

  Due to interfacing issues between the implant trial and inserter of the lumbar intervertebral fusion device.