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
Reported: November 22, 2017 Initiated: February 14, 2014 #Z-0102-2018
Product Description
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
Reason for Recall
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
Details
- Recalling Firm
- Zimmer Biomet, Inc.
- Units Affected
- 21 (4 US and 17 OUS)
- Distribution
- OH, MI and TX
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zimmer Biomet, Inc.. Units affected: 21 (4 US and 17 OUS).
Why was this product recalled? ▼
An undetected shift between the information displayed in the navigation software and the actual patient anatomy
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 22, 2017. Severity: Moderate. Recall number: Z-0102-2018.
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