CLASS II Device recall · Reported 4 Mar 2015 · FDA Enforcement Report

Offset Cup Impactor Universal recalled by Brainlab AG

Brainlab is recalling Offset Cup Impactor Universal, distributed nationwide in the US. The recall was initiated on 16 Jan 2015 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesModel 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.

Quantity recalled114 offset cup impactors

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-1215-2015
FDA event ID: 70291
Recalling firm: Brainlab, Feldkirchen, N/A
Classification: Class II
Status: Terminated
Recall initiated: 16 Jan 2015
FDA classified: 26 Feb 2015
Reported: 4 Mar 2015
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Device type: Hip & Knee Implants

Timeline

16 Jan 2015	Recall initiated by company
26 Feb 2015	Classified by FDA	+41 days
4 Mar 2015	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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)

Where it was distributed

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

Nationwide Arizona California Idaho Illinois Maryland Michigan Minnesota Ohio Oklahoma Oregon Tennessee Washington Wisconsin West Virginia

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

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