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.
Reported: November 4, 2015 Initiated: September 23, 2015 #Z-0162-2016
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.
Details
- Recalling Firm
- Materialise N.V.
- Units Affected
- 4
- Distribution
- Distributed in MI, ID, TX, and in France.
- Location
- Heverlee, N/A
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Materialise N.V.. Units affected: 4.
Why was this product recalled? ▼
Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 4, 2015. Severity: Moderate. Recall number: Z-0162-2016.
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