Agency classClass IIOur severity:High FDA (Devices)·Z-1248-2018·Announced 2018-04-04

Stryker Recalls Advanced Cement Mixing Kits Due to Sterility Concerns

Stryker is recalling 1,542 Advanced Cement Mixing Kits because bioburden levels exceeded acceptable rates, posing a sterility risk.

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: The recall involves a medical device with a sterility defect (bioburden) which poses a risk of harm, but the source text does not report any specific illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 1,542 units of the Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press. (Product Number: 0306-573-000). The recall is due to a lack of sterility assurance, as bioburden levels were found to be higher than internal acceptable rates.

The affected products are distributed in all 50 U.S. States and the District of Columbia, as well as in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and the United Kingdom. The specific lot numbers involved are 17282012, 17283012, 17297012, and 17298012.

Healthcare providers should stop using the affected kits and contact Stryker for further instructions. The FDA has classified this as a Class II recall.

The recalled product

Product: Advanced Cement Mixing (ACM) Kit w/ Femoral Breakaway Nozzle & Prox. Med. Press., Product Number: 0306-573-000, UDI: (01)4546540055415 for orthopedic use.
Manufacturer: Stryker Instruments Div. of Stryker Corporation
Category: Medical Device — Orthopedic
Hazard: sterility
bioburden
Affected units: 1,542

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 (4)

Lot Numbers: 17282012
17283012
17297012
17298012 UDI: (01)4546540055415

Distribution

Distributed in 1 state:

Part of a larger recall action

This product is one of 13 recalled by Stryker Instruments Div. of 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 13 products in this recall →

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Same hazard · sterility