9805 Orbital Volume Sizer Set with Tray — Class II medical device recall Z-1150-2017
Terminated recall by Stryker Leibinger GmbH & Co. KG, reported 2017-02-15, distributed nationwide. An incorrect sterility status on the label, non-sterile products labeled as sterile
| Recall number | Z-1150-2017 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Stryker Leibinger GmbH & Co. KG, Freiburg, N/A, Germany |
| Recall initiated | 2017-01-03 |
| Classified | 2017-02-08 |
| Reported by FDA | 2017-02-15 |
| Terminated | 2017-07-27 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, CA, CL, ES, TW, ZA |
| Quantity | 619 |
| Reason classes | labeling, sterility |
| Lot numbers | 85000, 9951, 9952, M1305001, M1311023, M1603003, M1603004 |
Product
9805 Orbital Volume Sizer Set with Tray (Non-sterile) 9951 Design M Malar Sizer Set (Silicone, Non-Sterile) 9952 Extended Contoured, Malar Sizer Set (Silicone, Non-Sterile) 85000 Petite Nasal Dorsum Sizer Set (Silicone, Non-Sterile) Accessories to Medpor Implants
Reason for recall
An incorrect sterility status on the label, non-sterile products labeled as sterile
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-1150-2017. 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.