Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) recallZ-1287-2015 · Materialise N.V. · initiated Feb 4, 2015
Class II Terminated All recalls posted in March 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
Images belonging to a different patient were used for the production of the patient specific surgical guide. The incorrect guide may cause a delay in surgery to accommodate the preparation and use of traditional instrumentation.
FDA root cause category: Employee error
What the company is doing
Materialise N.V. sent an email on February 4, 2015, to the the affected distributor regarding the reason for the recall, affected product, and instructions for removing the affected product. For questions regarding this recall call 321-639-6611.
Recall details
- Recall number
- Z-1287-2015
- Recall class
- Class II
- Status
- Terminated
- Initiated by the company
- Feb 4, 2015
- Posted by the FDA
- Mar 17, 2015
- Recalling firm
- Materialise N.V.
- Quantity
- 1 unit
- Product code
- JWH
- FDA submissions
- K102795
- Distribution
- Worldwide Distribution to the Netherlands only.
Product description
Signature TKA GDE/MDL Set 04-05 (Femur & Tibia) The Signature Patient-Specific Surgical Guides are intended to be used as part of the Signature Personalized Patient Care System. Lt is intended to be used as a guide during the surgical procedure for total and partial knee arthroplasty.
Code information (models, lots, serial numbers)
Lot# 124471
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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