# Zimmer Biomet safety record

15 incident(s) on file for Zimmer Biomet, rolled up across its models and deployments (operated or manufactured). Retracted claims are excluded from this count but remain reachable at their own canonical URLs.

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## Incidents (15)

- [FDA Class I recall: Zimmer Biomet ROSA Brain 3.0 robotic surgery system software anomaly](/incidents/recall-2026-06-15-zimmer-biomet.md) (2026-06-15): Recall · severity: catastrophic · FDA · recall ordered
- [Zimmer ROSA Recon: force sensor error and unintended robotic-arm drift during a knee case (FDA MAUDE)](/incidents/zimmer-rosa-recon-force-sensor-arm-drift-maude-2026.md) (2026-04-01): Malfunction · severity: serious · FDA (MAUDE)
- [Zimmer ROSA Recon: a large amount of sparks with a hole found in the power cord (FDA MAUDE)](/incidents/zimmer-rosa-recon-power-cord-sparks-maude-2026.md) (2026-03-09): Malfunction · severity: serious · FDA (MAUDE)
- [Zimmer ROSA Recon: reaming produced an oblong hole requiring a bone graft (FDA MAUDE)](/incidents/zimmer-rosa-recon-oblong-reaming-hole-maude-2024.md) (2024-06-24): Injury · severity: serious · FDA (MAUDE)
- [Zimmer Biomet ROSA ONE Brain 3.1 Class I recall: software could drive instruments to a wrong trajectory](/incidents/rosa-one-brain-trajectory-recall-2021.md) (2021-09-22): Recall · severity: critical · FDA · recall ordered
- [Zimmer Biomet recalls ROSA Brain 3.0 (Class I) over instrument holder following an incorrect trajectory](/incidents/zimmer-rosa-brain-3-incorrect-trajectory-recall-2020.md) (2019-09-10): Recall · severity: critical · FDA · recall ordered
- [Zimmer Biomet recalls ROSA Brain 3.0 over the robotic arm being sent to the wrong position](/incidents/zimmer-rosa-brain-3-arm-wrong-position-recall-2018.md) (2017-05-01): Recall · severity: serious · FDA · recall ordered
- [Zimmer Biomet recalls ROSA Spine 1.0.2 over the robotic arm being sent to the wrong position](/incidents/zimmer-rosa-spine-arm-wrong-position-recall-2018.md) (2017-05-01): Recall · severity: serious · FDA · recall ordered
- [Zimmer Biomet recalls ROSA Brain 3.0.0 over the head holder connector locking up when tightened](/incidents/zimmer-rosa-brain-300-head-holder-lockup-recall-2017.md) (2016-10-11): Recall · severity: serious · FDA · recall ordered
- [Zimmer Biomet recalls ROSA Brain 3.0 over insufficient washers allowing telescopic-arm movement](/incidents/zimmer-rosa-brain-3-telescopic-arm-movement-recall-2018.md) (2016-05-27): Recall · severity: serious · FDA · recall ordered
- [Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over software changing final tool orientation without command](/incidents/zimmer-rosa-258-tool-orientation-change-recall-2018.md) (2016-04-08): Recall · severity: serious · FDA · recall ordered
- [Zimmer Biomet recalls ROSA Herga Foot Switch over system freeze or shutdown in Fulgurate mode](/incidents/zimmer-rosa-herga-foot-switch-freeze-recall-2017.md) (2016-01-20): Recall · severity: serious · FDA · recall ordered
- [Zimmer Biomet ROSA 2.5.8 recalled over a force-feedback sensor failure that can stop the arm from halting](/incidents/zimmer-rosa-force-feedback-sensor-failure-recall-2018.md) (2014-11-06): Recall · severity: serious · FDA · recall ordered
- [Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over an undetected shift between navigation display and patient anatomy](/incidents/zimmer-rosa-258-navigation-anatomy-shift-recall-2018.md) (2014-02-14): Recall · severity: serious · FDA · recall ordered
- [Zimmer Biomet recalls ROSA Surgical Device 2.5.8 over observed device instability](/incidents/zimmer-rosa-258-device-instability-recall-2018.md) (2013-02-05): Recall · severity: serious · FDA · recall ordered

## Exposure

DEPLOY does not have exposure data (deployment-hours, miles driven, or rides given) on file for Zimmer Biomet's 2 recorded deployment(s). No incident count above can be turned into a defensible rate without it. NHTSA's SGO dataset itself does not publish exposure denominators; there is no standardized, regulator-verified nationwide source for AV fleet mileage or ride counts today.

## A note on NHTSA's crash-reporting data

Many of the incidents below are drawn from NHTSA's Standing General Order (SGO) 2021-01 crash-reporting program, which requires manufacturers and operators of automated driving systems (ADS) and advanced driver-assistance systems (ADAS) to report qualifying crashes. It is the only nationwide, cross-operator crash dataset that exists for this industry, and it is also, by NHTSA's own design and Consumer Reports' public assessment, an imperfect one.

Reporting companies may redact narrative fields as confidential business information (CBI). In practice this means narrative completeness is uneven across manufacturers in the underlying dataset: some incident reports read as full prose descriptions of what happened, others are replaced with boilerplate redacted text. This is a property of the source data, not of DEPLOY's editorial process; DEPLOY publishes what the filing discloses and states plainly when a fuller account is not publicly available.

The SGO dataset also does not publish exposure denominators (miles driven, hours operated, rides given) alongside crash counts, so a raw incident count cannot be turned into a rate without an independently sourced denominator. See "Exposure" below for what DEPLOY does and does not have on file for this company.

- [NHTSA: Standing General Order on Crash Reporting](https://www.nhtsa.gov/laws-regulations/standing-general-order-crash-reporting)
- [Consumer Reports: comments to NHTSA on incident reporting for ADS and Level 2 ADAS](https://advocacy.consumerreports.org/research/consumer-reports-comments-to-nhtsa-on-incident-reporting-for-automated-driving-systems-and-level-2-adas/)
- [Consumer Reports: statement on crash-reporting underreporting](https://advocacy.consumerreports.org/press_release/transportation-department-keeps-in-place-vital-car-crash-reporting-program-but-misses-chance-to-address-underreporting-consumer-reports-statement/)

## Common questions

**What is Zimmer Biomet's safety record?**

DEPLOY has 15 incidents on file for Zimmer Biomet, drawn from NHTSA's Standing General Order crash-reporting program and press coverage. Each incident below is individually sourced and dated; see the incident list for details.

**Is Zimmer Biomet safer than a human driver?**

DEPLOY does not have exposure data (miles driven or hours operated) on file for Zimmer Biomet, so no per-mile or per-hour safety rate can be computed from this registry today. This is a documented industry-wide data gap, not unique to DEPLOY: NHTSA's own SGO dataset does not publish exposure denominators alongside crash counts. Any rate comparison you see elsewhere may rely on a company's self-published mileage figures, which are not independently audited.

**Does DEPLOY redact or omit crash details for Zimmer Biomet?**

No. DEPLOY does not redact incident narratives. Where a source narrative is itself incomplete (for example, a NHTSA SGO filing redacted as confidential business information), DEPLOY states that plainly rather than filling the gap. See "A note on NHTSA's crash-reporting data" below.


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