Recalls / —

—#157472

Product

ROSA Surgical Device 2.5.8

FDA product code

HAW — Neurological Stereotaxic Instrument

Device class

Class 2

Medical specialty

Neurology

510(k) numbers

K092239, K101791

Affected lot / code info

Serial No. RO10011, RO10014, RO13023 and RO13027

Why it was recalled

Issue with optional neuro-endoscopy module detected under specific conditions during internal testing.

Root cause (FDA determination)

Software design

Action the firm took

Field Service Technicians were dispatched to correct units by upgrading the system to ROSA 2.5.7. A further update of ROSA 2.5.8.4. A Field Safety Notice dated 07/10/2013 notifying consignees of a risk in the ROSA system recognized in internal testing. It was suggested that consignees not utilize the neuro-endoscopy module until further notice. The recall notice should have been shared with the appropriate parties and the signed acknowledgement form returned to the recalling firm.

Recalling firm

Firm

Zimmer Biomet, Inc.

Address

1800 W Center St, Warsaw, Indiana 46580-2304

Distribution

Distribution pattern

AR, OH, MI, and TX

Timeline

Recall initiated

2013-02-10

Terminated

2020-06-09

Status

—

Source: openFDA Device Recall endpoint. Recall record ID #157472. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.