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Terminated

ROSA Surgical Device 2.5.8, a computer-controlled electromechanical arm to guide standard neurosurgical instruments.

FDA Recall Z-0160-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2014-11-06
Date Terminated2020-07-13
Product Quantity31 units

Reason for Recall

Potential failure of a force feedback sensor that may result in continued movement of an operating arm (rather than an immediate stop as intended).

Firm Action

All 9 domestic units were corrected by the firm in February 2017, via technician visits to consignee sites.

Root Cause

Device Design

Distribution Pattern

US distribution in AR, GA, OH, MI, and TX.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101791ROSA SURGICAL DEVICEMedtech S.A.S · 2010-09-23K092239ROSA SURGICAL DEVICE, MODEL ROSA 1.1Medtech S.A · 2009-11-17

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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