Product Wiki · Recalls · U.S. FDA — Device Enforcement

Recall Z-0162-2016 — 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.

U.S. FDA — Device Enforcement · Belgium · 2015-09-23 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-0162-2016
Date of alert: 2015-09-23
Country / jurisdiction: Belgium
Risk level: Class II
Risk type: recall
Brand: Materialise N.V.
Product category: device
Product type: Devices
Barcode (EAN/GTIN): 42422461

Reported risk: Potential inaccuracies in the alignment of the guides. Surgery was inaccurately planned because the patient image data was incorrectly processed.

Primary source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts

Verify each fact at the issuing agency before acting. Recall scope, affected lots, and remediation instructions may be updated by the agency after our last sync.

ProductGuru indexes recall and safety-alert records from ~30 public agency registries. We are not lawyers, regulators or product-safety consultants. This page restates what the named agency published; consult the primary source above (or qualified counsel in your jurisdiction) before any commercial, medical or safety decision.

Recall Z-0162-2016 — 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.

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