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Terminated

ROSA Surgical Device 2.5.8. It is intended to be used in the operating room for the spatial positioning and orientation of an instrument holder or tool guide

FDA Recall Z-0102-2018 · Posted None

Recalling FirmZimmer Biomet, Inc.
Recall StatusTerminated
Product CodeHAW
Date Initiated2014-02-14
Date Terminated2020-09-16
Product Quantity21 (4 US and 17 OUS)

Reason for Recall

An undetected shift between the information displayed in the navigation software and the actual patient anatomy

Firm Action

There were 4 units imported into the US and all have been corrected.

Root Cause

Error in labeling

Distribution Pattern

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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