The Recall Desk

Manufacturer

Zimmer Biomet Spine, Inc

8 recalls in our database name Zimmer Biomet Spine, Inc as the manufacturing or recalling firm.

What the numbers show

Total
8
Critical
0
Severe
0
Most recent
2024-01-10

Of the 8 recalls from Zimmer Biomet Spine, Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–8 of 8

  • HighFDA (Devices)·Z-0639-2024·2024-01-10

    Spinal fixation screws recalled due to incorrect size laser marking

    Zimmer Biomet Spine Inc. is recalling Vitality Polyaxial Screws (7.5mm x 50mm) due to incorrect laser marking showing 7.5 x 40. Incorrect screw size could cause perforation and vascular damage during spinal surgery.

    Product
    Vitality Polyaxial Screw, 7.5mmx 50mm, REF: 07.02000.118, used with Vitality and Vital Spinal Fixation System
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0867-2019·2019-03-06

    Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws

    Zimmer Biomet Spine Inc. is recalling Vitality Shear-off Set Screws because they do not thread properly with mating components due to a manufacturing issue.

    Product
    Vitality¿ Spinal Fixation System. Spinal Interlaminal, Appliance, Fixation, (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Scre
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0866-2019·2019-03-06

    Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws

    Zimmer Biomet is recalling Vitality Shear-off Set Screws because they do not thread properly with mating components due to a manufacturing issue.

    Product
    Vitality¿ Spinal Fixation System. Thoracolumbosacral pedicle screw system (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set Screw i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0868-2019·2019-03-06

    Zimmer Biomet Recalls Vitality Spinal Fixation Set Screws

    Zimmer Biomet Spine Inc. is recalling Vitality Shear-off Set Screws because a manufacturing issue prevents them from threading properly with mating components.

    Product
    Vitality¿ Spinal Fixation System.Spinal Intervertebral Body, Appliance, Fixation (non-sterile). Pedicle screw fixation is indicated for skeletally mature patients and for adolescent patients. For use in Orthopedic medical specialty area. Product Usage: The Vitality Shear-off Set
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2318-2017·2017-06-14

    Zimmer Biomet Recalls Vitality Spinal Fixation System Drivers

    Zimmer Biomet is recalling Vitality T27 Final Drivers and Torque Limiting Handles because they may create torsional springs that damage the device or cause torque values to go out of specification.

    Product
    Vitality Spinal Fixation System, Vitality T27 Final Drivers and Vitality Torque Limiting Handle  90 in-lbs Model Number(s): 07.02066.001, 07.02053.001, 730M0017
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-1691-2017·2017-04-05

    Zimmer Biomet Recalls Altius M-INI OCT Spinal Fixation System

    Zimmer Biomet is recalling 141 units of the Altius M-INI OCT Posterior Spinal Fixation System because the driver cannot mate with the screw head tulip.

    Product
    Altius M-INI OCT Posterior Spinal Fixation System, Model Number 1200-9216 The AltiusTM OCT and AltiusTM M-INITM OCT Systems when intended to promote fusion of the cervical spine and occipitocervico-thoracic junction (Occiput-T3), these systems are indicated for: DDD (neck pain o
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2397-2016·2016-08-17

    Zimmer Biomet Recalls Zyston Transform Instrument Cases Due to Locking Defect

    Zimmer Biomet Spine, Inc. is voluntarily recalling Zyston Transform Instrument Cases and Implant Kits because the implant locking mechanism is not functioning as intended.

    Product
    Zyston¿ Transform Instrument Case. Model Number PCR8200-2101. Device labeled sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-2398-2016·2016-08-17

    Zimmer Biomet Recalls Zyston Transform Implant Kits Due to Locking Defect

    Zimmer Biomet Spine is recalling five Zyston Transform Implant Kits because the locking mechanism is not functioning as intended.

    Product
    Zyston¿ Transform Implant Kit. Model Number PCR8200-3101. Device labeled sterile.
    Category
    Medical Device
    Distribution
    Distributed nationwide