Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
PCD Kit: Long 90 Recalled by Stryker Instruments Div. of Stryker Corporation Due to Lack of sterility assurance as bioburden levels were...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Stryker Instruments Div. of Stryker Corporation directly.
Affected Products
PCD Kit: Long 90, 13g Match-Ground w/ Bevel, Product Number: 0506-485-000, UDI: (01)4546540907035 for spinal orthopedic use.
Quantity: 12
Why Was This Recalled?
Lack of sterility assurance as bioburden levels were found to be higher than internal acceptable rates.
Where Was This Sold?
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.
About Stryker Instruments Div. of Stryker Corporation
Stryker Instruments Div. of Stryker Corporation has 161 total recalls tracked by RecallDetector.
Related Recalls
EndoVive Safety PEG Kit Recalled by Boston Scientific Corporation Due to Recall of kits which utilized ChloraPrep Triple Swabsticks...
Boston Scientific Corporation · February 10, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Artelon FlexBand Dynamic Matrix Ref: 31057 Recalled by International Life Sciences Due to Augmentation devices failed bacterial endotoxin testing.
International Life Sciences · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Owner's Booklets and Instructions for Use that are used with Recalled by Trividia Health, Inc. Due to The system labeling (user manual and online labeling)...
Trividia Health, Inc. · February 6, 2026
Data sourced from the FDA (Device). Last updated March 26, 2026. View original report