Z-0162-2016 Class II Terminated
FDA device recall Z-0162-2016 was initiated by Materialise N.V. on Sep 23, 2015 and is designated Class II. Reason for recall: Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed. The recall status is terminated (terminated Feb 12, 2016). Affected quantity: 4.
Recall details
- Product Type
- Devices
- Report Date
- Nov 4, 2015
- Initiation Date
- Sep 23, 2015
- Termination Date
- Feb 12, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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.
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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0162-2016
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026