Home › Device types › KQZ
Component, Traction, Non-Invasive
FDA product code KQZ · Class 1 · Orthopedic
102
Registered devices
42
Adverse events
9
Recalls
11
510(k) clearances
Devices with this code
BI-LATERAL KNEE ATTACHMENT — Biomet Orthopedics, LLCParadigm Revolution — Conmed CorporationArthrex® — ARTHREX, INC.BoneFoam — BONE FOAM, INC.20# WATER WEIGHT BAG — Bird & Cronin, LLCLEG POSITIONER PAD, 2 PK — Biomet Orthopedics, LLCFINGER TRAPS, 5 LARGE, LITEGRIP — MIZUHO ORTHOPEDIC SYSTEMS, INC.D.B.S. Dynamic Brace System — MEDITRAC LTD.BoneFoam — BONE FOAM, INC.Arthrex® — ARTHREX, INC.DISPOSABLE PAD-UNIVERSAL BOOT — Bird & Cronin, LLCFINGER TRAP, SMALL — MIZUHO ORTHOPEDIC SYSTEMS, INC.NA — MID CENTRAL MEDICAL CORP.Arthrex® — ARTHREX, INC.Arthrex® — ARTHREX, INC.BUCKS BOOT SM — Bird & Cronin, LLCN/A — Smith & Nephew, Inc.N/A — Smith & Nephew, Inc.Arthrex® — ARTHREX, INC.FINGER TRAPS, 5 EXTRA SMALL, LITEGRIP — MIZUHO ORTHOPEDIC SYSTEMS, INC.Arthrex® — ARTHREX, INC.Arthrex® — ARTHREX, INC.Top Shelf Orthopedics — Top Shelf Manufacturing, LLCN/A — Smith & Nephew, Inc.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2021-12-14 | Smith & Nephew, Inc. | Products were shipped to the Global Distribution Center instead of the sterilizer and therefore product did not undergo the sterilization process |
| 2018-06-21 | Ossur Americas | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line descript |
| 2018-06-21 | Ossur Americas | Halo system products labeled MR conditional will undergo confirmatory safety testing to confirm MR conditional parameters. In addition, the second line descript |
| 2016-03-14 | Ossur H / F | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. |
| 2016-03-14 | Ossur H / F | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. |
| 2016-03-14 | Ossur H / F | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. |
| 2016-03-14 | Ossur H / F | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. |
| 2016-03-14 | Ossur H / F | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. |
| 2016-03-14 | Ossur H / F | There is a potential for partial or complete fracture of the plastic stabilizer strap on the vest. |
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