The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)
Reported: March 4, 2015 Initiated: January 16, 2015 #Z-1215-2015
Product Description
The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument)
Reason for Recall
The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
Details
- Recalling Firm
- Brainlab AG
- Units Affected
- 114 offset cup impactors
- Distribution
- Worldwide Distribution - US: Nationwide (AZ, CA, ID, IL, MD, MI, MN, OH, OK, OR, TN, WA, WI, WV); Australia, Austria, Bahrain, Belgium, Germany, Hong Kong, India, Italy, Japan, Malaysia, Russian Federation, Saudi Arabia, South Korea, Spain, Switzerland, Thailand, United Arab Emirates, United Kingdom
- Location
- Feldkirchen, N/A
Frequently Asked Questions
What product was recalled? ▼
The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive orthopedic surgery. (a stereotaxic instrument). Recalled by Brainlab AG. Units affected: 114 offset cup impactors.
Why was this product recalled? ▼
The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 4, 2015. Severity: Moderate. Recall number: Z-1215-2015.
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