Home › Device types › JDZ
Mixer, Cement, For Clinical Use
FDA product code JDZ · Class 1 · Orthopedic
271
Registered devices
1,004
Adverse events
18
Recalls
13
510(k) clearances
Devices with this code
AutoPlex VertaPlex — STRYKER CORPORATIONCLEANEST — Guangzhou Clean Medical Products Manufacturing Corp.SMARTSET — DEPUY (IRELAND)Premium Plus — Premium Plus (Dongguan) LimitedCLEANEST — Guangzhou Clean Medical Products Manufacturing Corp.PALACOS® — Heraeus Medical GmbHQuick-Vac® Vacuum Mixing Bowl — SUMMIT MEDICAL LIMITEDPCD — STRYKER CORPORATIONAutoPlex, VertaPlex — STRYKER CORPORATIONCLEANEST — Guangzhou Clean Medical Products Manufacturing Corp.Premium Plus — Premium Plus International LimitedHiVac™ Bowl Bone Cement Mixing System — SUMMIT MEDICAL LIMITEDPremium Plus — Premium Plus International LimitedDarby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCNA — STRYKER CORPORATIONQuick-Vac Vacuum Mixing Bowl — SUMMIT MEDICAL LIMITEDACM — STRYKER CORPORATIONPURE KIT — TEKNIMEDPicoMix Bowl — G21 SRLPCD, VertaPlex — STRYKER CORPORATIONMixing Bowl — IMEDICOM CO., LTD.Darby Dental Supply, LLC — DARBY DENTAL SUPPLY, LLCPALACOS® — Heraeus Medical GmbHPALACOS® — Heraeus Medical GmbH
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-03-30 | Zimmer, Inc. | Ten complaints have been received identifying issues at the time of use related to the package seal, including incomplete seals, wrinkles in the seals or peelin |
| 2026-03-25 | Heraeus Medical GmbH (Dental Division) | Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lo |
| 2026-03-25 | Heraeus Medical GmbH (Dental Division) | Based on long-term stability testing, it was determined that in units older than 1.5 years (17 months) the mixing rod may, in rare cases, come loose from its lo |
| 2017-11-09 | Stryker Instruments Div. of Stryker Corporation | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| 2017-11-09 | Stryker Instruments Div. of Stryker Corporation | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| 2017-11-09 | Stryker Instruments Div. of Stryker Corporation | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| 2017-11-09 | Stryker Instruments Div. of Stryker Corporation | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| 2017-11-09 | Stryker Instruments Div. of Stryker Corporation | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| 2017-11-09 | Stryker Instruments Div. of Stryker Corporation | Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates. |
| 2013-11-01 | Stryker Instruments Div. of Stryker Corporation | On March 14, 2013 a Work Order was opened for 120 units (20 boxes) of the Acetabular Pressurizer (P/N 0206-522-000 Rev. H). On March 15, 2013, when the product |
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