Synthes Low Profile Neuro Screwdriver Blade Recalled for MR Safety Labeling
Synthes (USA) Products LLC is recalling 50 units of Low Profile Neuro Screwdriver Blades because the MR Safety information etched or labeled on the devices does not meet current ASTM standards.
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: The recall is classified as FDA Class II and involves a labeling error regarding MR Safety information that does not meet ASTM standards. This aligns with the rubric for moderate severity, specifically minor labeling errors or voluntary precautionary recalls where no immediate physical harm is reported.
Plain-English summary
Synthes (USA) Products LLC is voluntarily recalling 50 units of the Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short (Part #313.945, Lot # 5053859). These medical instruments are used to assist with the insertion or removal of an implant. The recall is initiated because the affected devices were distributed with MR Safety information that is etched or labeled in a way that does not meet the current ASTM standard.
The recalled units were distributed nationwide in the United States, specifically in the states of AR, CA, CO, CT, DC, ID, IL, KY, LA, MA, MD, MN, MO, MS, MT, NY, PA, and TX. The products were manufactured on July 28, 2005, and are non-sterile with no expiration date.
Healthcare facilities and users should stop using the affected devices and contact Synthes (USA) Products LLC for further instructions regarding the recall.
The recalled product
- Product
- Screwdriver Blade, Handle, Drill Bit, Part #313.945 Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short Lot # 5053859 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an implant.
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 50
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 (5)
- Part Number: 313.945
- Low Profile Neuro Screwdriver Blade/MR Safe/MQC/32mm Short
- Lot # 5053859
- mfg. 7/28/2005
- No Expiration Date product provided Non Sterile
Distribution
Part of a larger recall action
This product is one of 11 recalled by Synthes (USA) Products LLC 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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