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Terminated

ROSA Surgical Device 2.5.8

FDA Recall Z-0115-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2016-04-08
Date Terminated2020-07-13
Product Quantity64 units

Reason for Recall

Potential for software to change the final tool orientation for the command position without command.

Firm Action

Field Service Technicians visited consignee locations to perform system upgrades and have been completed.

Root Cause

Software design

Distribution Pattern

AL, AR, CA, CO, CT, FL, GA, KY, MA, MI, MO, NY, OH, PA, TX, and WA Canada, China, France, Germany, India, Israel, Italy, Russia, Saudi Arabia, Spain, and United Kingdom

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K101791ROSA SURGICAL DEVICEMedtech S.A.S · 2010-09-23

Official Source

View FDA Recall →

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

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