Recall Z-1215-2015 ยท OLO Orthopedic Stereotaxic Instrument
Brainlab AG
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)
| Date | Feb 26, 2015 (initiated Jan 16, 2015) |
| Status | Terminated |
| Reason | The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level. |
| Root cause | Reprocessing Controls |
| Action | FIELD SAFETY NOTICE / PRODUCT NOTIFICATION letters dated December 11, 2014 were sent to all direct accounts (customers). The letters included instructions for customers to utilize the sterilization cycles included in the letter. Customers were further advised to alert users of these devices to the sterilization process changes. Customers with questions can contact Brainlab by telephone at 800-597-5911 or via e-mail at us.support@brainlab.com. |
| Quantity | 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 |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K122011 | NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP Brainlab AG, Nov 15, 2012 |