Stryker Recalls Intramedullary Brushes Due to Sterility Assurance Failure
Stryker is recalling 320 Intramedullary Brushes because bioburden levels exceeded acceptable rates, compromising sterility assurance.
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 assurance failure (bioburden levels exceeding acceptable rates). Per the rubric, this is a risk-of-harm product where injury has not yet been reported, warranting a High severity score.
Plain-English summary
Stryker Instruments Div. of Stryker Corporation is recalling 320 units of the Intramedullary Brush Standard O.D. 14 mm (Product Number: 6198-001-514, UDI: (01)4546540255853). 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 identified by Lot Number 17284012. These devices were 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.
Healthcare providers and facilities should stop using the affected lots and contact Stryker for further instructions on return or replacement.
The recalled product
- Product
- Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
- Manufacturer
- Stryker Instruments Div. of Stryker Corporation
- Affected units
- 320
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: 17284012 UDI: (01)4546540255853
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.
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