Agency classClass IIOur severity:High FDA (Devices)·Z-2598-2023·Announced 2023-09-27

Stryker ACM Advanced Cement Mixing System Nozzle May Disassemble

Stryker is recalling the ACM bone cement mixing system because the break-away femoral nozzle may disassemble or break off during surgery, potentially causing loss of device function and components to fall into 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: FDA Class II recall of a surgical device where component failure could cause loss of device function and introduction of foreign material into the surgical site. No illnesses or injuries have been reported; the hazard is potential. Per the rubric, a risk-of-harm product without reported injury scores 3 (High).

Plain-English summary

Stryker Corporation is recalling the Advanced Cement Mixing (ACM) System with femoral break-away nozzle (applicator tip) used to mix bone cement under high vacuum during orthopedic surgery.

The break-away femoral nozzle may disassemble or break off during use. If this occurs, the device may lose function and components may fall into the surgical site, creating a foreign body hazard and potential contamination of the surgical field.

The recall affects 5,155 units in the United States and 1,607 units distributed to Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Malaysia, Poland, Singapore, South Korea, Spain, Taiwan, Thailand, and the United Kingdom. Fifty-three lot numbers are affected.

Healthcare facilities should immediately discontinue use of affected devices and contact Stryker for replacement units. Facilities should review any surgical procedures performed with affected lots.

The recalled product

Product: Stryker ACM (Advanced Cement Mixing) System: ACM Kit w/ Femoral Breakaway Nozzle-Allows the user to mix bone cement witha constant high vacuum through the process Catalog Number: 0306-563-000
Manufacturer: Stryker Corporation
Category: Medical Device — Orthopedic Surgical Equipment
Hazard: component-breakage
loss-of-function
foreign-body-hazard

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 →

Same manufacturer · Stryker Corporation

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Same hazard · component breakage