The Recall Desk

Manufacturer

Zimmer Biomet, Inc.

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

What the numbers show

Total
875
Critical
0
Severe
129
Most recent
2020-12-30

Of the 875 recalls from Zimmer Biomet, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 129 (15%) 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.

701–725 of 875

  • ModerateFDA (Devices)·Z-0177-2018·2017-12-06

    Zimmer Biomet Recalls Two Rosa Spine Stereotaxic Devices for Software Bugs

    Zimmer Biomet is recalling two Rosa Spine 1.0.2 devices worldwide to resolve software bugs and improve stability.

    Product
    Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by surgeons to guide standard neurosurgical instruments during spine surgery. Guidance is
    Category
    Medical Device
    Distribution
    0 states
  • ModerateFDA (Devices)·Z-0184-2018·2017-12-06

    Zimmer Biomet Recalls ROSA Surgical Device Due to Software Issue

    Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue in the MXTTOUT controller parameter settings.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0167-2018·2017-11-29

    Zimmer Biomet ROSA Brain 3.0.0 Software Recall for Communication Errors

    Zimmer Biomet is recalling 18 units of ROSA Brain 3.0.0 software due to communication errors between software components and the controller.

    Product
    ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments (biopsy needle, stimulation or recording electrode, endoscope). The device i
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-0160-2018·2017-11-29

    FDA Recalls Zimmer Biomet ROSA Surgical Devices Due to Sensor Failure

    The FDA is recalling 31 Zimmer Biomet ROSA Surgical Devices because a force feedback sensor may fail, causing the operating arm to continue moving instead of stopping.

    Product
    ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
    Category
    Medical Device
    Distribution
    5 states
  • HighFDA (Devices)·Z-0105-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Brain 3.0 Neurosurgical Devices

    Zimmer Biomet is recalling three ROSA Brain 3.0 neurosurgical devices due to insufficient washers in the telescopic arm that allow unwanted movement.

    Product
    ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by neurosurgeons to guide standard neurosurgical instruments. The device is indicated for any neurosurgical procedure in which the use of stereotactic surgery may
    Category
    Medical Device
    Distribution
    0 states
  • HighFDA (Devices)·Z-0115-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Surgical Device Due to Software Error

    Zimmer Biomet is recalling 64 ROSA Surgical Device 2.5.8 units because a software defect may change tool orientation without user command.

    Product
    ROSA Surgical Device 2.5.8
    Category
    Medical Device
    Distribution
    16 states
  • ModerateFDA (Devices)·Z-0161-2018·2017-11-29

    Zimmer Biomet Recalls ROSA Surgical Device Software

    Zimmer Biomet is recalling 29 ROSA Surgical Devices due to a software issue affecting cooperative endoscopy mode.

    Product
    ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed with three-dimensional imaging software, and uses fiducial marker
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0099-2018·2017-11-22

    Zimmer Biomet Recalls ROSA Surgical Devices Due to Observed Instability

    Zimmer Biomet is recalling 53 ROSA Surgical Devices because of observed instability. The devices are computer-controlled arms used in neurosurgery.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0100-2018·2017-11-22

    Zimmer Biomet Recalls ROSA Surgical Device Due to Optical Sensor Failure

    Zimmer Biomet is recalling 14 ROSA Surgical Devices because a cable disconnection may cause the optical distance sensor to fail.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed
    Category
    Medical Device
    Distribution
    2 states
  • HighFDA (Devices)·Z-0096-2018·2017-11-22

    Zimmer Biomet ROSA Surgical Device Recalled for Potential Force Sensor Break

    Zimmer Biomet is recalling 21 ROSA Surgical Devices due to a possible break in the Force Sensor connector. The devices were distributed to facilities in Ohio, Michigan, and Texas.

    Product
    ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide. Guidance is based on a pre-operative plan developed
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • HighFDA (Devices)·Z-0102-2018·2017-11-22

    Zimmer Biomet Recalls ROSA Surgical Device Due to Navigation Software Shift

    Zimmer Biomet is recalling 21 ROSA Surgical Devices because an undetected shift between the navigation software display and actual patient anatomy was identified.

    Product
    ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide
    Category
    Medical Device
    Distribution
    3 states
  • HighFDA (Devices)·Z-0070-2018·2017-11-15

    Zimmer Biomet Recalls Custom Titanium Knee Implant Due to Nickel Content

    Zimmer Biomet is recalling a custom titanium knee implant because it contained a nickel-containing screw, posing a risk to a patient with a nickel allergy.

    Product
    Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patient anatomy.
    Category
    Medical Device
    Distribution
    0 states
  • SevereFDA (Devices)·Z-3175-2017·2017-10-04

    Zimmer Biomet Recalls Straight Shank Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 62 units of 4.0 mm Straight Shank Drill Bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Straight Shank Drill Bits 4.0 mm Diameter, Item Number/EDI 00231804006, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3157-2017·2017-10-04

    Zimmer Biomet Recalls NCB Periprosthetic Plate System Drill Bits

    Zimmer Biomet is recalling 185 NCB Periprosthetic Plate System Drill Bits due to a raw material anomaly that may increase the risk of instrument fracture during use.

    Product
    NCB Periprosthetic Plate System Drill Bit With Quick-Coupling 4.5 mm Diameter 195 mm Length, Item Number/EDI 0200024330, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3150-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Quick-Connect Drills

    Zimmer Biomet is recalling 4 units of ECT Internal Fracture Fixation Quick-Connect Drills due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill, 1.5 mm Diameter, 85mm Length, Item Number/EDI 00241001500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3178-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Screw Taps Due to Material Anomaly

    Zimmer Biomet is recalling 198 nonsterile orthopedic screw taps because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Zimmer Periarticular Locking Plate System, Locking Screw Tap Standard Quick-Connect 3.5 mm Diameter, Item Number/EDI 00236015335, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3188-2017·2017-10-04

    Zimmer Biomet Recalls ECT Internal Fracture Fixation Quick-Connect Drill Bits

    Zimmer Biomet is recalling 10 units of ECT Internal Fracture Fixation Quick-Connect Drills due to a raw material anomaly that may increase the risk of instrument fracture during use.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill 4.0 mm Diameter 20cm Length, Item Number/EDI 00241004000, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3199-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling 15 nonsterile orthopedic drill bits because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3158-2017·2017-10-04

    Zimmer Biomet Recalls M/DN Intramedullary Fixation Distal Drill Pilot Tips

    Zimmer Biomet is recalling 182 M/DN Intramedullary Fixation Distal Drill Pilot Tips due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI 00225503332, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3191-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may cause the instruments to fracture during use.

    Product
    Drill Bit Jacobs Chuck 3.2 mm Diameter 130 mm Length, Item Number/EDI 00480513032, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3181-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Drills and Screw Taps

    Zimmer Biomet is recalling 1,129 orthopedic surgical drills and screw taps due to raw material anomalies that may increase the risk of instrument fracture.

    Product
    Zimmer Periarticular Locking Plate System Drill Standard 2.7 mm Diameter, Item Number/EDI 00236020527, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3187-2017·2017-10-04

    Zimmer Biomet Recalls ECT Quick-Connect Drills Due to Fracture Risk

    Zimmer Biomet is recalling 62 ECT Internal Fracture Fixation Quick-Connect Drills because raw material anomalies may cause the instruments to fracture during use.

    Product
    ECT Internal Fracture Fixation Quick-Connect Drill 3.5 mm Diameter 11 cm Length, Item Number/EDI 00241003500, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3196-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Drill Bits Due to Fracture Risk

    Zimmer Biomet is recalling specific orthopedic drill bits and screw taps because raw material anomalies may increase the risk of instrument fracture during use.

    Product
    Drill Bit Quick-Connect 3.5 mm Diameter 110 mm Length, Item Number/EDI 00480611035, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide
  • SevereFDA (Devices)·Z-3160-2017·2017-10-04

    Zimmer Biomet Recalls Orthopedic Surgical Instruments Due to Fracture Risk

    Zimmer Biomet is recalling 21 units of M/DN Intramedullary Fixation Femoral Drills because raw material anomalies may cause the instruments to fracture during use.

    Product
    M/DN Intramedullary Fixation Femoral Drill Large 5.0 mm Item Number/EDI 00225503550, Nonsterile. orthopedic surgical instrument.
    Category
    Medical Device
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Zimmer Biomet Holdings

medical device company

Country
United States
Founded
1927

Official website

Source: Wikidata (Q203552), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.