Brainlab AG: Medical Device Recall in 2015 - (Recall #: Z-1215-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

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 Classification:

Class II

Date Initiated: January 16, 2015

Date Posted: March 4, 2015

Recall Number: Z-1215-2015

Event ID: 70291

Reason for Recall:

The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.

Status: Terminated

Product Quantity: 114 offset cup impactors

Code Information:

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 Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated