The Recall Desk
Agency classClass IIOur severity:SevereFDA (Devices)·Z-1243-2018·Announced 2018-04-04

Stryker Recalls Break-Away Femoral Nozzles Due to Sterility Concerns

Stryker is recalling 384 Break-Away Femoral Nozzles because bioburden levels were found to be higher than acceptable rates, posing a risk of infection.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, an FDA Class II recall involving a medical device with a sterility failure (risk of infection) is rated as Severe (4), as it carries a significant risk of harm even without reported hospitalizations in the text.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 384 units of the Break-Away Femoral Nozzle, Product Number 0206-512-000, for orthopedic use. The recall was initiated because bioburden levels were found to be higher than the company's internal acceptable rates, indicating a lack of sterility assurance.

The affected products, identified by Lot Number 17279012 and UDI (01)4546540039415, were distributed in all 50 U.S. states, the District of Columbia, and in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, the Netherlands, and the United Kingdom.

Healthcare providers and facilities should stop using the affected nozzles immediately and contact Stryker for instructions on return or replacement. Patients who have had these devices used during a procedure should consult their healthcare provider if they experience signs of infection.

The recalled product

Product
Break-Away Femoral Nozzle, Product Number: 0206-512-000, UDI: (01)4546540039415 for orthopedic use.
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
384

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)

  • Lot Number: 17279012 UDI: (01)4546540039415

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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