The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-1251-2018·Announced 2018-04-04

Stryker Recalls 30 Revolution 90 Degree Tibial Nozzles for Sterility Issues

Stryker is recalling 30 units of the Revolution 90 Degree Tibial Nozzle 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 is classified as FDA Class II. The hazard involves a lack of sterility assurance (bioburden), which is a risk-of-harm condition for a medical device where injury has not yet been reported, fitting the 'High' severity criteria.

Plain-English summary

Stryker Instruments Div. of Stryker Corporation is recalling 30 units of the Revolution 90 Degree Tibial Nozzle (Product Number: 0606-516-000, UDI: (01)4546540911971). The recall is due to a lack of sterility assurance, as bioburden levels were found to be higher than internal acceptable rates.

The affected product is an orthopedic device distributed in all 50 U.S. states, the District of Columbia, and several international countries including Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, the Netherlands, and the United Kingdom. The specific lot number for the recalled units is 17293012.

Healthcare providers and consumers should stop using the affected product immediately and contact Stryker for further instructions on return or replacement.

The recalled product

Product
Revolution 90 Degree Tibial Nozzle, Product Number: 0606-516-000, UDI: (01)4546540911971 for orthopedic use.
Manufacturer
Stryker Instruments Div. of Stryker Corporation
Category
Medical Device — Orthopedic Instrument
Hazard
Affected units
30

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: 17293012 UDI: (01)4546540911971

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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