FDA Device recall Z-1941-2016
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set
- FDA Device
- Class II
- terminated
- Published 2016-06-15
On 2016-06-15 the FDA classified a Class II recall of Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set by Materialise Usa, citing 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….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1941-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2016-05-03 |
| Published | 2016-06-15 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Materialise Usa |
| Distribution | IN |
Product
Signature TKA GDE/MDL Set 04-05 Patient-specific surgical guide and instrument set.
Reason
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.
Identifiers
| code_info | Lot #154970 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1941-2016%22
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