Home › ON-X LIFE TECHNOLOGIES, INC. › Chord-X Premeasured Loops and Suture System
Chord-X Premeasured Loops and Suture System
ON-X LIFE TECHNOLOGIES, INC. · Model CXL-20-2212-0 · UDI-DI 00813570020008
PAW
Prescription
1
510(k) clearances
10
Adverse events (1 deaths)
1
Recalls
4
Facilities
Description
Artificial chordal replacement prosthesis
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-12-13 | On-X Life Technologies, Inc. | Four 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 fo |
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