Signature Patient-Specific Surgical Guides recallZ-0162-2016 · Materialise N.V. · initiated Sep 23, 2015
Class II Terminated All recalls posted in October 2015
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Materialise N.V. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
FDA root cause category: Use error
What the company is doing
On September 16, 2015 Materialise NV identified four cases where not all available image sets were used to design the case. On September 18, 2015, prior to the surgery dates Materialise informed (phone call) the Signature Services Manager of Zimmer Biomet that inaccuracies in the alignment of the knee might be observed with the use of the guides due to this issue. Biomet was asked to segregate the packages for these four cases and to return them to the Materialise US office. On September 23, 2015 this was followed up by e-mail notification letter with response forms. Biomet was requested to contact Materialise customer service to return these four cases and arrange a replacement set of patient specific surgical guides Monday through Friday, 8:00 AM to 4:30 PM, Eastern Time. E-mail : ortho-quality@materialise. be Customer Service Materialise USA LLC 44650 Helm Court Plymouth, Michigan 48170 734-259-7033
Recall details
- Recall number
- Z-0162-2016
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Sep 23, 2015
- Posted by the FDA
- Oct 23, 2015
- Recalling firm
- Materialise N.V.
- Quantity
- 4
- Product code
- OSF
- FDA submissions
- K102795
- Distribution
- Distributed in MI, ID, TX, and in France.
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.
Code information (models, lots, serial numbers)
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 devices under the same FDA submission
1 device cleared under K102795 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Signature 42-422551Materialise NV · Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive2 reports
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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