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

Recall Z-1322-2015 — The Rheo Knee bionic prosthetic is to be used exclusively for fittings of lower extremity amputations. RHEO KNEE uses Artificial Intelligence to continuously adapt to the users walking style and environment. The RHEO KNEE recognizes and responds immediately to changes in speed, load and terrain, r

U.S. FDA — Device Enforcement · Iceland · 2015-02-26 · Class II

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Agency: U.S. FDA — Device Enforcement
Recall identifier: Z-1322-2015
Date of alert: 2015-02-26
Country / jurisdiction: Iceland
Risk level: Class II
Risk type: recall
Brand: Ossur H / F
Product category: device
Product type: Devices

Reported risk: The firm is recalling Rheo Knee bionic prosthetic due to it being discovered during an internal audit of the service line that devices were released for distribution without fully going through the assembly process.

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.

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