The Brainlab Offset Cup Impactor Universal — Class II medical device recall Z-1215-2015
Terminated recall by Brainlab AG, reported 2015-03-04, distributed nationwide. The recommended sterilization and drying parameters are not effective to achieve the minimum required steriliz
| Recall number | Z-1215-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Brainlab AG, Feldkirchen, N/A, Germany |
| Recall initiated | 2015-01-16 |
| Classified | 2015-02-26 |
| Reported by FDA | 2015-03-04 |
| Terminated | 2017-03-13 |
| Distributed | Nationwide (US) |
| Countries outside the US | AE, AT, AU, BE, BH, CH, DE, ES, GB, HK, IN, IT, JP, KR, MY, SA, TH |
| Quantity | 114 offset |
| Model numbers | 52856ABL, 52856BL |
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 for recall
The recommended sterilization and drying parameters are not effective to achieve the minimum required sterilization level.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1215-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.