Agency classClass IIOur severity:High FDA (Devices)·Z-2599-2023·Announced 2023-09-27

Stryker ACM Cement Mixer Nozzle Risk of Disassembly During Surgery

Stryker is recalling certain ACM (Advanced Cement Mixing) systems due to risk that the Break-Away Femoral Nozzle may disassemble or break during use, potentially causing loss of function and components entering the surgical site.

The agency’s classification

FDA (Devices): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: Class II recall of surgical equipment with potential for functional failure and foreign material entry into the surgical site. No injuries or illnesses have been reported; severity reflects risk-of-harm from equipment failure during use.

Plain-English summary

Stryker Corporation is recalling the ACM (Advanced Cement Mixing) System, catalog number 0306-564-000, specifically the ACM Kit with Femoral Breakaway Nozzle and Solid Blades. The Break-Away Femoral Nozzle is the applicator tip connecting the cement cartridge to the mixing device.

The nozzle has the potential to disassemble or break off during surgical use. If this occurs, the system may lose function and components may fall into the surgical site, creating a risk of foreign material contamination during orthopedic procedures.

This recall affects 8 units in the U.S. and internationally to Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Malaysia, Poland, Singapore, South Korea, Spain, Taiwan, Thailand, and the UK. The affected lot numbers are 22305012 and 22336012.

The recalled product

Product: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle & Solid Blades-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-564-000
Manufacturer: Stryker Corporation
Category: Medical Device — Orthopedic Surgical Equipment
Hazard: equipment-failure
foreign-object-risk
loss-of-function
Affected units: 8

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

GTIN: 04546540899071 Lot Numbers: 22305012 22336012

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 7 recalled by Stryker Corporation under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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