DEPLOYDatabase

Company

Zimmer Biomet

Zimmer Biomet, American orthopedic medical device company developing robotic surgery platforms ( Rosa) for joint replacement surgery.

Track Zimmer Biomet
HQ
Warsaw, IN
Status
public (NYSE: ZBH)

The verified answer

As of Aug 2026, DEPLOY verifies Zimmer Biomet: 1 model, 15 active incidents. 3 sources back the record.

Regulatory status2 FDA 510(k) clearances1 FDA recall

Zimmer Biomet holds 2 FDA 510(k) clearances and has 1 FDA recall on record, per the DEPLOY registry.

See all 3 filings
PublicNYSE: ZBH

CategorySurgical robots

Models

1

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Key facts

Product

ROSA robotic surgical assistant (Knee/Hip/Brain/Shoulder); cross-domain ortho + neuro.

Boundary

AI-augmented surgeon-controlled assistance, NOT autonomous (autonomy is the separate Monogram line).

Stock listing

NYSE: ZBH

ROSA origin

ROSA originated at Medtech SA

Acquisition year

Medtech SA acquired in 2016

ROSA platform

ROSA Knee (with OptimiZe, FDA-cleared Nov 2025), ROSA Brain, ROSA Spine

ROSA Knee price

$700,000-$1,500,000

Data & sources

Press releases

2

Web sources

1

3 sources backing this record.View all →

Models (1)

View all models →

Current platform

ROSA

ROSA, the Robotic Surgical Assistant, is Zimmer Biomet's surgeon-controlled robotic-arm platform, recorded in the surgical form factor as the mid-size, multi-procedure archetype of the orthopedic sub-cohort and the one that crosses surgical sub-domains, spanning orthopedics and neurosurgery from a single robotic-arm and navigation architecture. The arm is coupled to optical navigation and two- and three-dimensional planning software and positions or guides instruments, but it moves only on surgeon command and does not cut or place autonomously, so ROSA is AI-augmented surgeon-controlled assistance rather than autonomous surgery and is in scope as a surgical robot. Made by Zimmer Biomet Holdings, listed on the New York Stock Exchange as ZBH and headquartered in Warsaw, Indiana, ROSA originated at the French company Medtech SA, founded in 2002 in Montpellier by Bertin Nahum, which built ROSA Brain and ROSA Spine; Zimmer Biomet acquired Medtech SA in 2016 at fifty euros per share and extended the ROSA arm into orthopedics. The current Zimmer Biomet variants are ROSA Knee for total knee arthroplasty, cleared January 25, 2019 and enhanced as ROSA Knee with OptimiZe cleared November 14, 2025, ROSA Hip for direct anterior total hip arthroplasty cleared August 18, 2021, ROSA ONE Brain for cranial neurosurgery including biopsy, stereo-electro-encephalography, deep brain stimulation, and ventricular and transnasal endoscopy cleared February 11, 2019, and ROSA Shoulder for shoulder arthroplasty cleared in February 2024. ROSA ONE Spine, cleared in 2019, left Zimmer Biomet in the March 2022 ZimVie spinoff and is no longer a Zimmer Biomet product. A registry nuance worth recording is that autonomy enters Zimmer Biomet's portfolio separately through its Monogram Technologies acquisition, completed October 7, 2025, which brings a CT-based semi-autonomous total-knee robot and a fully-autonomous version in development; this is kept distinct from ROSA, whose surgeon-controlled status is unchanged. Installed-base figures circulating in aggregators conflict and none is asserted here.

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Zimmer Biomet on the deployment map

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Relationships

PPeritasAITechnology partnerNNVIDIATechnology partner

Explainers

Plain-language answers to the questions people ask about Zimmer Biomet, from DEPLOY’s explainer library. Each is written in the language of the question and cross-checked against this registry.

What is Zimmer Biomet ROSA?
Zimmer Biomet ROSA (Robotic Surgical Assistant) is a mid-size cross-domain multi-procedure surgical robotic platform from Zimmer Biomet Holdings (NYSE: ZBH). Per Agent A orthopedic ingest: cleared for knee + hip (direct-anterior) + brain (SEEG/DBS) + shoulder; ROSA brain technology came via Medtech SA acquisition 2016 + subsequent extension to orthopedics. CRITICAL CORRECTIONS per Agent A: (1) ROSA Spine LEFT Zimmer Biomet in the 2022 ZimVie spinoff (NOT a current ZB variant); (2) ZB autonomy enters via SEPARATE Monogram acquisition, NOT ROSA (kept distinct so AI-augmented-not-autonomous framing holds across the orthopedic sub-cohort consistently). AI-augmented surgeon-controlled assistance (same assistive class as Mako + CORI + da Vinci + Maestro). Cohort positioning: mid-size cross-domain multi-procedure platform spanning orthopedics + neurosurgery within the Wave 3 orthopedic sub-cohort triangle.Read the full explainer →
How does DEPLOY track acquisition history state?
DEPLOY tracks acquisition history state as a five-structure taxonomy operating at relationship-graph granularity per Agent A's Arc D substrate (29 acquisitions + 20 FK-acquirer + 9 external + 7 acquired-assets typed). The structure taxonomy: full_acquisition (acquirer absorbs target entirely; target ceases as independent entity) → asset_purchase (specific assets transfer; target may continue) → acqui_hire (team transfers; assets minimal) → license_and_hire (Amazon × Covariant canonical: RFM models licensed + team transitions; Covariant remains standalone under Stinson; ~25% staff transition documented) → spac_merger (de-SPAC pattern; Sarcos → Palladyne canonical example). The four-state valuation_basis discipline: exact (SEC-disclosed or court-record) versus reported (press-release; not SEC-verifiable) versus undisclosed (transaction confirmed but valuation not disclosed) versus contingent (ZB × Monogram CVR canonical: structured contingent payment with earnout). The canonical lesson banked at validator-discipline depth: exact name match only, never alias-contains, in M&A graphs (6 acquisitions reverted from alias-contains reconciliation bug). Cap-flag-as-trust-signal operates recursively on acquisition framing.Read the full explainer →
How does DEPLOY track the 2021 ROSA ONE Brain wrong-trajectory Class I recall?
DEPLOY tracks the 2021 Zimmer Biomet ROSA ONE Brain 3.1 wrong-trajectory Class I recall at primary-source-anchored FDA-recall-database verification depth as a software_defect Class I recall within the ZB cluster's neurosurgical-platform product line. The substrate: urgent correction issued September 22, 2021 + FDA Class I designation November 2021; on reboot after an unexpected shutdown following patient registration, selecting 'clear the robotic arm' and running empty-device calibration could drive the device to an incorrect trajectory, sending a tool to the wrong brain location (stroke / serious-injury risk); 119 US devices at exact verification depth; 3 complaints (one inaccurate electrode placement); no patient injuries reported; software corrective update rolled out 2022; remediated. Root cause: software_defect (post-reboot calibration sequence could misinterpret coordinates and drive an instrument to an incorrect trajectory). The framework reads the incident at four substrate layers simultaneously: incident-recall actuarial depth per Phase 3 Dim 1 (severity=critical at primary-source-anchored verification; software_defect root cause; remediated status); within-ZB-cluster verification scope at sub-product-line granularity (ROSA ONE Brain neurosurgical platform vs ROSA Spine vs Mako orthopedic vs Monogram orthopedic per ZB cluster densest in corpus); cross-property acquisition history bidirectional compounding (ZB cluster ROSA ONE Brain retained per ZimVie spinoff 2022 vs ROSA Spine LEFT ZB in 2022 ZimVie spinoff per Agent A correction; ZB acquired Monogram closed October 7, 2025 ~$168M EV + CVR canonical contingent valuation_basis worked example per acquisition history Project B methodology pillar); software_defect root cause class with remediation discipline at primary-source-anchored verification depth. Cap-flag honest-absence at exact recall Z-number not captured from primary FDA pages; reputable-press source-quality tier per FierceBiotech + Becker's coverage of FDA recall record.Read the full explainer →

Current leadership (2)

Board (1)

Former / Previously (1)

  • Greg Roche Global President, Robotics & Technologysecondary-verified

Media (1)

Company-anchored media. Official assets the company has published at the company level, distinct from model-anchored media that lives on individual product pages.

Safety record

12 recalls and 3 incidents on record (1 catastrophic, 2 critical, 12 serious). Most recent: Jun 2026.

catastrophic
1
critical
2
serious
12
recall
12
malfunction
2
injury
1

Most recent: Jun 2026

Only active incidents are counted. Retracted incidents are excluded from this summary but remain reachable at their canonical URLs.

Full safety record: incidents, sourcing, and exposure data →

Incidents affecting Zimmer Biomet (15)

Includes incidents linked directly to this company, to its models, or to deployments of its models or under its operation. Retracted incidents are excluded from this view but remain reachable at their canonical URLs.

Recent coverage

Zimmer Biomet in third-party press

Zimmer Biomet: $1 Billion Buyback Target Expands As Next-Generation ROSA Shoulder Begins First Procedures

Aug 12, 2026

Zimmer Biomet Announces Second Quarter 2026 Financial Results

Aug 5, 2026

Zimmer Biomet to Hire 500 in India as New Bengaluru Technology Centre Drives AI and MedTech Innovation

Jul 8, 2026

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