Signature TKA GDE/MDL Set 04-05 — Class II medical device recall Z-1287-2015
Terminated recall by Materialise N.V., reported 2015-03-25. Images belonging to a different patient were used for the production of the patient specific surgical guide. T
| Recall number | Z-1287-2015 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Materialise N.V., Heverlee, Belgium |
| Recall initiated | 2015-02-04 |
| Classified | 2015-03-17 |
| Reported by FDA | 2015-03-25 |
| Terminated | 2015-10-30 |
| Countries outside the US | NL |
| Quantity | 1 units |
| Lot numbers | 124471 |
Product
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
Reason for recall
Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
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-1287-2015. 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.