Z-1215-2015Class II

The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided...

Name: Z-1215-2015 The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided...
Creator: Brainlab AG
Published: 2015-01-16
License: https://open.fda.gov/license/

Brainlab, Inc. / initiated 2015-01-16 / Terminated / root cause: sterility

FDA source

Brainlab AG began a recall of The Brainlab Offset Cup Impactor Universal. Part of the Brainlab hip system. An intraoperative image-guided localization system to enable minimally invasive... on 2015-01-16. FDA classified it as Class II and gives the reason as "The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1215-2015
Classification: Class II
Status: Terminated
Initiated: 2015-01-16
Posted: 2015-02-26
Terminated: 2017-03-13
Recalling firm: Brainlab, Inc.
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)
Product code: OLO Orthopedic Stereotaxic Instrument
Reason for recall: The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
Root cause tag: sterility
FDA 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 [email protected].
Quantity in commerce: 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
Product codes and lots: 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.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1215-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1215-2015	Class II	Terminated	Voluntary: Firm initiated	2015-03-04	2015-02-26

Product code OLO

K122011Class IINavigation Software Hip-Universal; Navigation Software Hip Thr-AesculapBrainlab AG / cleared 2012-11-15

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)