FDA Device recall Z-1215-2015
The Brainlab Offset Cup Impactor Universal
- FDA Device
- Class II
- terminated
- Published 2015-03-04
On 2015-03-04 the FDA classified a Class II recall of The Brainlab Offset Cup Impactor Universal by Brainlab Ag, citing the recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1215-2015 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-01-16 |
| Published | 2015-03-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Brainlab Ag |
| Distribution | US |
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)
Reason
The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
Identifiers
| code_info | Model 52856 BL CURVED CUP INSERTER UNIVERSAL SHAFT; and MODEL 52856A BL OFFSET CUP IMPACTOR UNIVERSAL SHAFT, all serial…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. |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1215-2015%22
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