Agency classClass IIOur severity:High FDA (Devices)·Z-2601-2023·Announced 2023-09-27

Stryker ACM System Femoral Nozzle Recall for Potential Disassembly

Stryker is recalling its ACM Advanced Cement Mixing System due to a defect in the Break-Away Femoral Nozzle that can disassemble or break off during surgical use, risking loss of device function and foreign material in 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: This is a Class II medical device recall involving risk-of-harm in a surgical setting (components falling into the surgical site with bio-incompatibility risk). No illnesses or injuries have been reported. Per the severity rubric, risk-of-harm products where injury has not yet been reported warrant a score of 3 (High).

Plain-English summary

Stryker Corporation is recalling the ACM (Advanced Cement Mixing) System, specifically units featuring the Break-Away Femoral Nozzle component (Catalog Number 0306-703-000). This device is used to mix bone cement with constant high vacuum during orthopedic surgical procedures.

The Break-Away Femoral Nozzle, which serves as the applicator tip connecting the cement cartridge, can disassemble or break off during use. This defect can lead to loss of function of the ACM system and creates a bio-incompatibility risk due to components potentially falling into the surgical site.

Sixteen units were recalled in the United States. The device was also distributed to Austria, Belgium, Canada, France, Germany, Hong Kong, Italy, Malaysia, Poland, Singapore, South Korea, Spain, Taiwan, Thailand, and the United Kingdom. The affected lot number is 23010012.

The recalled product

Product: Stryker ACM (Advanced Cement Mixing)System: ACM Kit w/ Femoral Breakaway Nozzle, Restrictors & Prox. Press-Allows the user to mix bone cement with a constant high vacuum through the process Catalog Number: 0306-703-000
Manufacturer: Stryker Corporation
Category: Medical Device — Surgical / Orthopedic
Hazard: device-malfunction
foreign-material
bio-incompatibility
Affected units: 16

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: 07613327051285 Lot Numbers: 23010012

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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