Zimmer Biomet Recalls
875 recalls on record · January 20, 2016 to December 30, 2020 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
January 10, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls OSS CEMENTED IM STEM 12X150, model # 150366
Hazard: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
January 10, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls CER BIOLOXD OPTION HD 32MM, model # 650-1056
Hazard: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
January 10, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls CER OPTION TYPE 1 TPR SLEVE -6, model # 650-1064
Hazard: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
January 10, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls ECHO POR FMRL NC 9X125, model # 192009
Hazard: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
January 10, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls COMP PRIMARY STEM 8MM MINI, model # 113628
Hazard: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
January 10, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls COMP 12MM HUM FRAC STEM MACRO, model # 11-113562
Hazard: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
January 10, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Lateral Troch Plate Full Crimp - 254mm, model # 350838
Hazard: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
January 10, 2018Medical DevicesFDA
Zimmer Biomet, Inc. recalls Lateral Troch Plate Full Crimp - 254mm, model # 350837
Hazard: Possibility that the patient label inside the product box was incorrectly labeled. The outer box label and actual product are correctly identified but the internal patient label could be incorrect.
December 27, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls ExploR Radial Head Replacement System. PN: 11-210061 LN: 243610. The stem is placed inside a polyurethane bag. The ba
Hazard: Zimmer Biomet is conducting a medical device recall for the ExploR 6x24mm Implantable Stem with Screw due to a complaint alleging that the Modular Radial HD lock screw was not included in the package for the stem.
December 6, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be us
Hazard: The software issue described was corrected in the modification to the MXTTOUT controller parameter settings.
December 6, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8
Hazard: Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.
December 6, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Rosa Spine 1.0.2 Stereotaxic Instrument Computer-Assisted Surgical Device The device is intended for the spatial positi
Hazard: A design change was initiated to update ROSA Spine 1.0.2 to version ROSA Spine 1.0.2.16 to resolve software bugs and improve usability and stability of the ROSA Spine device.
November 29, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA Brain 3.0.0 Usage: The device is intended for the spatial positioning and orientation of instrument holders or
Hazard: Communication errors between ROSANNA BRAIN software, MARIO software and the St¿ubli CS8C controller.
November 29, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8 It is intended to be used in the operating room for the spatial positioning and orientat
Hazard: Software corrections reactivating the cooperative endoscopy mode.
November 29, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.
Hazard: Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).
November 29, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA BRAIN 3.0.0
Hazard: Non-conforming product label.
November 29, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8
Hazard: Potential for software to change the final tool orientation for the command position without command.
November 29, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA Brain 3.0 Intended for the spatial positioning and orientation of instrument holders or tool guides to be used by
Hazard: Insufficient amount of washers in the Telescopic Arm, allowing some movement of the device.
November 22, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientat
Hazard: An undetected shift between the information displayed in the navigation software and the actual patient anatomy
November 22, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be us
Hazard: Potential failure of the optical distance sensor due to cable disconnection.
November 22, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be u
Hazard: Observed instability of the device.
November 22, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls ROSA Surgical Device 2.5.8 ROSA Surgical Device is a computer-controlled electromechanical arm. It is intended to be us
Hazard: Possible break in the connector of the Force Sensor.
November 15, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Custom Ti MAK RS OSS Segmental Femoral Rotating Hinged Knee. This Rotating Hinged Knee is intended to replace patien
Hazard: A custom implant manufactured entirely from titanium for a patient with a nickel allergy was requested by a surgeon. After the device was manufactured and used in the planned surgery, it was discovered internally that the implant assembly had a CoCrMo screw included as a component of the implant, which contains nickel.
October 4, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Drill Bit Quick-Connect 3.2 mm Diameter 195 mm Length, Item Number/EDI 00480619532, Nonsterile. orthopedic surgical inst
Hazard: Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
October 4, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Drill Bit Quick-Connect 4.5 mm Diameter 145 mm Length, Item Number/EDI 00480614545, Nonsterile. orthopedic surgical inst
Hazard: Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
October 4, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Zimmer Natural Nail System Freehand Drill 4.3 mm Diameter 152.5 mm Length, Item Number/EDI 00249007543, Nonsterile. orth
Hazard: Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
October 4, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Drill Bit Quick-Connect Calibrated 3-Fluted 2.5 mm Diameter 230 mm Length, Item Number/EDI 00480723025, Nonsterile. orth
Hazard: Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
October 4, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Drill Bit Quick-Connect 3-Fluted 4.5 mm Diameter 195 mm Length, Item Number/EDI 00480719545, Nonsterile. orthopedic sur
Hazard: Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
October 4, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Drill bit Quick-Connect 3-Fluted 2.5 mm Diameter 180 mm Length, Item Number/EDI 00480718025, Nonsterile. orthopedic surg
Hazard: Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.
October 4, 2017Medical DevicesFDA
Zimmer Biomet, Inc. recalls Drill Bit Quick-Connect 3.2 mm Diameter 145 mm Length, Item Number/EDI 00480614532, Nonsterile. orthopedic surgical inst
Hazard: Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.