On-X Life Technologies Inc.
2 recall(s) on record — most severe on record: Class II.
Activity by year
- Recalls (2)
Devices registered here (1)
- Prosthesis, Wrist, Carpal TrapeziumProduct code KYI (opens in a new tab) · Class II · Orthopedic · 21 CFR 888.3770
Recalls & enforcement
- Class IIOngoing2026-02-01Heart valves were released and distributed before all required testing was complete, so it cannot be confirmed that they meet all release specifications.
- Class IITerminated2016-12-13Four issues were uncovered by the recalling firm's CAPA: 1) Burrs were found to be present on Left Housing, Right Housing and Barrel components, 2) Loose plastic particulate was found within sealed primary packages, 3) Loose hair was discovered within four sealed primary packages…
Related
Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)
Cite this record
RegWarden. “On-X Life Technologies Inc. (FEI 3001584317) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3001584317-on-x-life-technologies-inc/
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