Stryker Spine Recalls Instructions for Use Due to Sterile Marking Error
Stryker Spine is recalling 40 units of Instructions For Use for TRIO+ Standard Post Screws because the front cover was incorrectly marked with a 'Sterile' logo.
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 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is a labeling error (mis-labeling) where the IFU incorrectly displays a 'Sterile' logo for non-sterile products. It is classified as Moderate because it is a documentation/labeling issue that could cause confusion but does not involve a direct physical defect in the device itself or reported injuries.
Plain-English summary
Stryker Spine is recalling 40 units of Instructions For Use (IFU) #NOLI135B03Rev02 for specific Stryker TRIO+ Standard Post Screws. The recall is due to a labeling error where the front cover of the IFU was improperly marked with a 'Sterile' logo in the lower right corner.
The post screws associated with these instructions are sold as 'Non-Sterile' and require sterilization before use in surgery. The incorrect 'Sterile' marking on the IFU could lead to confusion regarding the sterilization status of the devices. The affected units were distributed in Atlanta, Georgia.
Healthcare providers and facilities that have received these specific IFUs should stop using them and contact Stryker Spine for further instructions. The recall involves specific lot numbers and part numbers for the 4.5 mm and 5.5 mm Standard Post Screws.
The recalled product
- Product
- The Instructions For Use for the following: Stryker TRIO+ 4.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 50 mm STANDARD POST SCREW Stryker TRIO+ 4.5 x 55 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 45 mm STANDARD POST SCREW Stryker TRIO+ 5.5 x 60 mm STANDARD POST SCREW…
- Manufacturer
- Stryker Spine
- Hazard
- Affected units
- 40
Distribution
Distributed in 1 state:
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