Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and… — Class II medical device recall Z-1941-2016
Terminated recall by Materialise USA LLC, reported 2016-06-15, distributed in IN. A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which
| Recall number | Z-1941-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Materialise USA LLC, Plymouth, MI, United States |
| Recall initiated | 2016-05-03 |
| Classified | 2016-06-09 |
| Reported by FDA | 2016-06-15 |
| Terminated | 2016-06-28 |
| Distributed | IN |
| Quantity | 1 |
| Lot numbers | 154970 |
Product
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Reason for recall
A patient specific case of Signature Personalized Patient Care System Knee Guides included a femur guide which does not match the patient associated with the case. If the issue is not identified prior to surgery, the personalized patient specific guide would provide an improper fit and would not be able to be used.
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-1941-2016. 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.