Signature Patient-Specific Surgical Guides; patient specific instruments used as a guide during s...
FDA Device Recall #Z-0162-2016 — Class II — September 23, 2015
Recall Summary
| Recall Number | Z-0162-2016 |
| Classification | Class II — Moderate risk |
| Date Initiated | September 23, 2015 |
| Status | Terminated |
| Voluntary | Voluntary: Firm initiated |
Recalling Firm
| Firm | Materialise N.V. |
| Location | Heverlee, N/A |
| Product Type | Devices |
| Quantity | 4 |
Product Description
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.
Distribution Pattern
Distributed in MI, ID, TX, and in France.
Lot / Code Information
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
Other Recalls from Materialise N.V.
| Recall # | Classification | Product | Date |
|---|---|---|---|
| Z-2287-2023 | Class II | ProPlan CMF Patient-Specific Guide, Mandible gu... | Jun 19, 2023 |
| Z-2213-2023 | Class II | MRI Biomet Pin Guide for Total Knee Arthroplast... | Apr 26, 2023 |
| Z-2886-2020 | Class II | Match Point System The Match Point System is... | Jul 17, 2020 |
| Z-1484-2020 | Class II | TRUMATCH Orthognathic - Full Bimaxillary Surgic... | Feb 3, 2020 |
| Z-1485-2020 | Class II | TRUMATCH Orthognathics - Genioplasty Surgical K... | Feb 3, 2020 |
Frequently Asked Questions
Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.
Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.
Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.
What Should You Do?
Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.