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Cement, Bone, Vertebroplasty
FDA product code NDN · Class 2 · Orthopedic
0
Registered devices
4,892
Adverse events
86
Recalls
108
510(k) clearances
Devices with this code
Zavation — Zavation LLCMEDINAUT Kyphoplasty System — IMEDICOM CO., LTD.iVAS — STRYKER CORPORATIONMEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.SYNTH™ PLUS BILATERAL — IMEDICOM CO., LTD.StabiliT® — Merit Medical Systems, Inc.CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.MEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.Zavation — Zavation LLCSYNTH™ PLUS — IMEDICOM CO., LTD.SYNTH™ PLUS — IMEDICOM CO., LTD.Zavation — Zavation LLCCD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.SYNTH™ PLUS BILATERAL — IMEDICOM CO., LTD.BIOPSYBELL — BIOPSYBELL SRLMEDINAUT Plus Kyphoplasty System — IMEDICOM CO., LTD.CD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.Zavation — Zavation LLCCD HORIZON® Fenestrated Screw Set — MEDTRONIC SOFAMOR DANEK, INC.Zavation — Zavation LLCiVAS — STRYKER CORPORATIONKYPHON® Xpede™ Bone Cement and KYPHON® Mixer Pack — MEDTRONIC SOFAMOR DANEK, INC.Zavation — Zavation LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2022-12-15 | TEKNIMED SAS | Incorrect expiry date. Product is labeled with expiry date 2027-02-28. The correct expiration date is 2025-02-28. |
| 2021-05-18 | Stryker Spine | The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. |
| 2021-05-18 | Stryker Spine | The products experienced a 12-hour excursion from the required refrigerated temperature conditions at the distribution center prior to distribution. |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
| 2021-03-25 | Zavation | Products distributed as sterile may not have been adequately sterilized |
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