RegWardenFDA facility compliance records
Facility

ISOTIS ORTHOBIOLOGICS, INC

9 recall(s) on record — most severe on record: Class II.

Activity by year

FDA actions on record by year2024: 5 recalls; 2025: 2 recalls, 1 inspections; 2026: 2 recalls, 1 warning letters2017201820192020202120222023520243202532026
  • Recalls (9)
  • Inspections (1)
  • Warning letters (1)

Devices registered here (2)

  • Filler, Bone Void, Osteoinduction (W/O Human Growth Factor)
    Product code MBP (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3045
  • Filler, Bone Void, Calcium Compound
    Product code MQV (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3045

Recalls & enforcement

  • Class IIOngoing2026-08-19
    The proximal thread depth of the spinal device is out of design specification.
  • Class IIOngoing2026-05-28
    Due to manufacturing error, polyaxial head may popoff from the screw intraoperatively following insertion.
  • Class IIOngoing2025-11-17
    The NorthStar OCT Navigation Surgical Technique Guide (STG) incorrectly identified both Medtronic s Solera and Medtronic s Infinity system toolcards as compatible with the NorthStar OCT Navigation Instruments. However, the NorthStar OCT Navigation Instruments are compatible for u…
  • Class IIOngoing2025-08-06
    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 instrumentat…
  • Class IIOngoing2024-10-29
    Due to manufacturing defects observed on Locking Caps that affect the ability for components to mate.
  • Class IIOngoing2024-06-04
    Insufficient weld around the cap component of the instrument is insufficient to withstand impaction forces.
  • Class IIOngoing2024-05-17
    Cranial Caudal Blades manufactured incorrectly could result in fracture and/or damage to the bone structure
  • Class IIOngoing2024-02-28
    Screw heads, of pedicle screw systems, have partial thread within the screw head that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.
  • Class IIOngoing2024-02-15
    Screw heads, of pedicle screw systems, have thin lead-in thread that pose a risk of intraoperative cross-threading within the locking cap/screw head interface.

FDA inspections (1)

  • OAI2025-10-17
    Official Action Indicated · Compliance: Devices · citations posted

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

FDA warning letters (1)

Source: U.S. FDA Compliance Actions Dashboard (opens in a new tab) (device warning letters, 2016–present). Data as of 2026-10-06. Each link opens an FDA search for the letter; FDA can take several weeks to post a letter, so a very recent one may not appear yet.

Related

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “ISOTIS ORTHOBIOLOGICS, INC (FEI 3001503333) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001503333-isotis-orthobiologics-inc/

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