CLASS II Device recall · Reported 4 Nov 2015 · FDA Enforcement Report
Signature Patient-Specific Surgical Guides recalled by Materialise N.V
Materialise N.V is recalling Signature Patient-Specific Surgical Guides, distributed in Idaho, Michigan, Texas. The recall was initiated on 23 Sep 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0162-2016
- FDA event ID
- 72425
- Recalling firm
- Materialise N.V, Heverlee, N/A
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Sep 2015
- FDA classified
- 23 Oct 2015
- Reported
- 4 Nov 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Labeling Errors
- Device type
- Hip & Knee Implants
Timeline
| 23 Sep 2015 | Recall initiated by company | |
| 23 Oct 2015 | Classified by FDA | +30 days |
| 4 Nov 2015 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
Product as listed by the FDA
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.
Where it was distributed
Distributed in MI, ID, TX, and in France.
Questions about this recall
Why was it recalled?
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
Which lots are affected?
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
Where was it sold?
Distributed in MI, ID, TX, and in France.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Materialise N.V
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | ProPlan CMF Patient-Specific Guide, Mandible guides recalled | Materialise N.V | Other | Nationwide |
| Device | CLASS II | MRI Biomet Pin Guide for Total Knee Arthroplasty recalled | Materialise N.V | Other | N/A |
| Device | CLASS II | Match Point System The Match Point System is intended recalled | Materialise N.V | Nitrosamine Impurity | Nationwide |
| Device | CLASS II | Trumatch Orthognathics - Genioplasty Surgical Kit, Add recalled | Materialise N.V | Packaging Defects | NY |
| Device | CLASS II | Trumatch Orthognathic - Full Bimaxillary Surgical Kit recalled | Materialise N.V | Packaging Defects | NY |
Other Hip & Knee Implants recalls
All 3,097| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Medline convenience kits labeled as: Femoral Pack, Medline Kit recalled | Medline Industries | Other | Nationwide |
| Device | CLASS II | Arvis Surgical Navigation System Gen recalled by Kico Knee Innovation | Kico Knee Innovation | Device Malfunction | 19 states |
| Device | CLASS II | Veritas Standard Reverse Total Shoulder Veritas Standard recalled | restor3d | Device Malfunction | Nationwide |
| Device | CLASS II | Endo-Model, Replacement Set, Tibial Plateau, right/left, L, Uhmwpe recalled | Waldemar Link GmbH & Co. KG (Mfg Site) | Other | IN |
| Device | CLASS II | U2 Total Knee System Femoral offset bushing recalled | United Orthopedic | Device Malfunction | Nationwide |