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Dispenser, Cement
FDA product code KIH · Class 1 · Orthopedic
237
Registered devices
456
Adverse events
5
Recalls
11
510(k) clearances
Devices with this code
Kyphon V™ Osteo Introducer® 11 Ga Trocar/Bevel KIT — MEDTRONIC SOFAMOR DANEK, INC.BONE INJECTION NEEDLE beveled tip 15 Gauge 120 mm length — TECRES SPADJO SURGICAL — Encore Medical, L.P.Optivac Nozzle Slim — BIOMETKYPHON® EXPRESS™ Directional Bone Filler Device — MEDTRONIC SOFAMOR DANEK, INC.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.n/a — MEDTRONIC SOFAMOR DANEK, INC.Pressurizer — ADLER ORTHO SPA6mm Slim Flexible Nozzle — SUMMIT MEDICAL LIMITEDNA — Zimmer, Inc.KYPHON® Cement Delivery System — MEDTRONIC SOFAMOR DANEK, INC.JET-VAC — Smith & Nephew, Inc.Bone Cement Injection Gun — Shanghai Kinetic Medical Co., Ltd.Medtronic Reusable Instruments — MEDTRONIC SOFAMOR DANEK, INC.KYPHON® Express™ Directional Bone Filler Device — MEDTRONIC SOFAMOR DANEK, INC.Miller™ — Zimmer, Inc.Pressurizer — ADLER ORTHO SPASmartMix™ Narrow Straight Nozzle — SUMMIT MEDICAL LIMITEDMendec® Kypho Set Monolateral 10 mm — TECRES SPAMiller™ — Zimmer, Inc.PALAMIX® — Heraeus Medical GmbHRight-Angle Nozzle — BIOMETPALACOS® — Heraeus Medical GmbHSMALL DIAMETER CEMENT PREPARATION — Biomet Orthopedics, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-02-28 | Zimmer Biomet, Inc. | Lack of an adequate sterilization validation |
| 2015-08-20 | Orthovita, Inc., dBA Stryker Orthobiologics. | Two isolated instances of holes in the outer header bag component of the double barrier sterile packaging configuration |
| 2015-05-14 | BIOMET FRANCE S.A.R.L. | The pin which maintains the knob button, may disconnect and become lost. This may result in a delay of surgery to obtain a new Optigun and detect/retrieve the |
| 2012-01-13 | Stryker Instruments Div. of Stryker Corporation | The firm identified two complaints have been reported indicating that the product inside the package did not match with the label information. The product was l |
| 2011-03-31 | Orthovita, Inc. | Recalling firm has discovered through internal testing that the Cortoss(TM) Delivery Gun may abrade its packaging material under certain transportation and hand |
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