Z-1287-2015 Class II Terminated
FDA device recall Z-1287-2015 was initiated by Materialise N.V. on Feb 4, 2015 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Oct 30, 2015). Affected quantity: 1 unit.
Recall details
- Product Type
- Devices
- Report Date
- Mar 25, 2015
- Initiation Date
- Feb 4, 2015
- Termination Date
- Oct 30, 2015
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1 unit
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.
Reason for recall
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.
Distribution pattern
Worldwide Distribution to the Netherlands only.
Code information
Lot# 124471
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-1287-2015
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026