Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
Reported: April 4, 2018 Initiated: November 9, 2017 #Z-1255-2018
Product Description
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.
Reason for Recall
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Details
- Recalling Firm
- Stryker Instruments Div. of Stryker Corporation
- Units Affected
- 320
- Distribution
- Distributed in all 50 U.S. States and the District of Columbia. Distributed in Australia, Argentina, Japan, Canada, Chile, Korea, Spain, France, Italy, Netherlands, and United Kingdom.
- Location
- Portage, MI
Frequently Asked Questions
What product was recalled? ▼
Intramedullary Brush Standard O.D. 14 mm, Product Number: 6198-001-514, UDI: (01)4546540255853 for orthopedic use.. Recalled by Stryker Instruments Div. of Stryker Corporation. Units affected: 320.
Why was this product recalled? ▼
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on April 4, 2018. Severity: Moderate. Recall number: Z-1255-2018.
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