Agency classClass IIOur severity:High FDA (Devices)·Z-2596-2023·Announced 2023-09-27

Stryker ACM Bone Cement Mixer Nozzle May Break During Surgery

Stryker ACM bone cement mixing system nozzles may break or disassemble during surgical use, causing loss of function and risk of material fragments in the surgical site. Users should stop using affected units.

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 with potential for device failure and foreign material entry into a surgical site. No illnesses or injuries have been reported, meeting the criterion for High severity: risk-of-harm product where injury has not yet been reported.

Plain-English summary

Stryker Corporation is recalling the Break-Away Femoral Nozzle used in the Stryker ACM (Advanced Cement Mixing) System (Catalog number 0206-512-000). This nozzle is the applicator tip that connects the cement cartridge and is used during orthopedic surgery to mix bone cement under constant high vacuum.

The nozzle may disassemble or break off during use. If this occurs, the ACM system loses function and fragments may enter the surgical site. There is a risk of biocompatibility concerns if nozzle components remain in the wound.

Approximately 109 units were distributed in the United States and 290 units internationally to Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Malaysia, Poland, Singapore, South Korea, Spain, Taiwan, Thailand, and the United Kingdom. The affected lot numbers are 22314012 and 22336012.

Users should stop using units with the affected lot numbers and contact Stryker immediately. Healthcare providers should review their inventory and take appropriate action to prevent the use of recalled units during surgical procedures.

The recalled product

Product: Stryker ACM (Advanced Cement Mixing) System: Break-Away Femoral Nozzle-, Allows the user to mix bone cement with a constant high vacuum through the process. Catalog number: 0206-512-000.
Manufacturer: Stryker Corporation
Category: Medical Device — Surgical Equipment
Hazard: device-fracture
loss-of-function
foreign-material-in-wound
biocompatibility-issue

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: 04546540039415 Lot Numbers: 22314012 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 →

Same manufacturer · Stryker Corporation

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Same hazard · device fracture