Brainlab Offset Cup Impactor Universal Recall Due to Sterilization Failure
Brainlab AG is recalling 114 Offset Cup Impactor Universal units because their sterilization parameters are ineffective. The recall covers units distributed worldwide prior to January 13, 2015.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II. The hazard involves a failure to achieve minimum required sterilization levels, which is a significant risk of harm (infection) for a medical device, but the source text does not report specific injuries or hospitalizations, placing it in the High severity category per the rubric.
Plain-English summary
Brainlab AG is recalling 114 units of the Brainlab Offset Cup Impactor Universal, a component of the Brainlab hip system used for intraoperative image-guided localization in minimally invasive orthopedic surgery. The recall affects Model 52856 BL CURVED CUP INSERTER UNIVERSAL SHAFT and Model 52856A BL OFFSET CUP IMPACTOR UNIVERSAL SHAFT, specifically those with serial or lot numbers distributed prior to January 13, 2015.
The recall was initiated because the recommended sterilization and drying parameters for these devices are not effective to achieve the minimum required sterilization level. This defect poses a risk of inadequate sterilization during the reprocessing of the instruments.
The affected units were distributed worldwide, including nationwide in the United States (AZ, CA, ID, IL, MD, MI, MN, OH, OK, OR, TN, WA, WI, WV) and in numerous international markets such as Australia, Austria, Germany, and the United Kingdom. Healthcare facilities and users should stop using the affected devices and contact Brainlab AG for further instructions on return or replacement.
The recalled product
- Product
- 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)
- Manufacturer
- Brainlab AG
- Affected units
- 114
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Model 52856 BL CURVED CUP INSERTER UNIVERSAL SHAFT
- and MODEL 52856A BL OFFSET CUP IMPACTOR UNIVERSAL SHAFT
- all serial/lot numbers distributed prior to January 13
- 2015.
Distribution
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