FDA Device recall Z-0162-2016
Signature Patient-Specific Surgical Guides
- FDA Device
- Class II
- terminated
- Published 2015-11-04
On 2015-11-04 the FDA classified a Class II recall of Signature Patient-Specific Surgical Guides by Materialise N V, citing potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0162-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-23 |
| Published | 2015-11-04 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Materialise N V |
| Distribution | ID, MI, TX |
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
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
Identifiers
| code_info | 42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-…42422461: Signature SIG CT/TI(A Guides 04-05 Slidex Distal-MP/Premier Tibial & 42422551 : Signature TKA GDE/MDL SET 03-05 MP/Premier Distal- MP/Premier Tibial 42422461 139540 2016-02-17 42-422551 1 391 51 2016-01-14 42422551 1 38805 2016-02-03 42-422551 140787 2016-03-03 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0162-2016%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.