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PALAMIX®

Heraeus Medical GmbH · Model UNO · UDI-DI 04260102133587

JDZ Prescription

510(k) clearances

1,003

Adverse events (4 deaths)

Recalls

132

Facilities

Description

PALAMIX® is a vacuum mixing and application system for bone cements. It consists of: –PALAMIX® uno or PALAMIX® duo vacuum mixing system PALAMIX® uno and PALAMIX® duo allow for automatic collection of bone cement within the mixing cartridge under vacuum.

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 peeling seals. Compromised
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 lock during the mixing
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 lock during the mixing
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 was going to be plac

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.