Reported Mar 4, 2015 · Terminated
The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided…
Brainlab AG
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Brainlab AG · Kapellenstrasse 12 · Feldkirchen, N/A · N/A
Is this the product you have?
- 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)
- Lot codes and dates
- 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.
- Amount recalled
- 114 offset cup impactors
Where it was sold
Why it was recalled
The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
This product could cause temporary or reversible health problems — stop using it.
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