Signature Patient-Specific Surgical Guides — Class II medical device recall Z-0162-2016
Terminated recall by Materialise N.V., reported 2015-11-04, distributed in ID, MI, TX. Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient im
| Recall number | Z-0162-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Materialise N.V., Heverlee, N/A, Belgium |
| Recall initiated | 2015-09-23 |
| Classified | 2015-10-23 |
| Reported by FDA | 2015-11-04 |
| Terminated | 2016-02-12 |
| Distributed | ID, MI, TX |
| Countries outside the US | FR |
| Quantity | 4 |
Product
Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during surgical procedure for total and partial knee arthroplasty. Part of the Signature Personalized Patient Care System.
Reason for recall
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
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-0162-2016. 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.