The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization
FDA device recall Z-1215-2015 · posted 2015-02-26 · Terminated
Recall details
- Recalling firm
- Brainlab AG
- Reason for recall
- The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
- Action taken
- 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.
- Root cause
- Reprocessing Controls
- Status
- Terminated
- Product code
- OLO
- Quantity 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 Feder
- Date initiated
- 2015-01-16
- Date posted
- 2015-02-26
- Date terminated
- 2017-03-13
- Location
- Feldkirchen, Germany
Monitor recalls programmatically
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| NAVIGATION SOFTWARE HIP-UNIVERSAL; NAVIGATION SOFTWARE HIP THR-AESCULAP (K122011) | Brainlab AG | 2012-11-15 |