Home › Device types › KIH
Dispenser, Cement
FDA product code KIH · Class 1 · Orthopedic
237
Registered devices
461
Adverse events
5
Recalls
11
510(k) clearances
Devices with this code
Cement Delivery System — BIOMETAliquot — Stryker CorporationTELIGEN — Medos International SàrlSMARTSET — DEPUY (IRELAND)VIPER — Medos International SàrlMiniMix™ Delivery Syringe — SUMMIT MEDICAL LIMITEDPALACOS® — Heraeus Medical GmbHn/a — MEDTRONIC SOFAMOR DANEK, INC.Knee Cementation Nozzle — BIOMETMiller™ — Zimmer, Inc.Vertebroplasty Needle Kit, 8G, Diamond Tip — Möller Medical GmbHSmartMix™ Vacuum Syringe — SUMMIT MEDICAL LIMITEDKYPHON® Directional Bone Filler Device — MEDTRONIC SOFAMOR DANEK, INC.BONE INJECTION NEEDLE diamond tip 11 Gauge 120 mm length — TECRES SPA6mm Slim Flexible Nozzle — SUMMIT MEDICAL LIMITEDN/A — MEDTRONIC SOFAMOR DANEK, INC.DJO SURGICAL — Encore Medical, L.P.JET-VAC — Smith & Nephew, Inc.Kyphon Express Bone Biopsy Device — MEDTRONIC SOFAMOR DANEK, INC.PALACOS® — Heraeus Medical GmbHPALACOS® — Heraeus Medical GmbHBONE INJECTION NEEDLE diamond tip 15 Gauge 120 mm length — TECRES SPAKyphon ELEMENT Bone Filler Device — MEDTRONIC SOFAMOR DANEK, INC.Optigun Ratchet — BIOMET
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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