Synthes Recalls Matrix Neuro Screwdriver Blades for MR Safety Labeling Errors
Synthes (USA) Products LLC is recalling 18 Matrix Neuro Screwdriver Blades because their MR Safety labeling 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 standards. Per the rubric, minor labeling errors and voluntary precautionary recalls without reported injuries fall under the Moderate severity category.
Plain-English summary
Synthes (USA) Products LLC is voluntarily recalling 18 units of the Matrix Neuro Screwdriver Blade (Part # SD313.012). The affected lots are UR75221 and UR80162, manufactured between July 18, 2007, and August 2, 2007. These instruments are used to assist with the insertion or removal of implants.
The recall was initiated because the devices were distributed, etched, and/or labeled with MR Safety information that does not meet the current ASTM standard. This labeling discrepancy affects the accuracy of the safety information provided for use in MRI environments.
The affected units were distributed nationwide in the following states: AR, CA, CO, CT, DC, ID, IL, KY, LA, MA, MD, MN, MO, MS, MT, NY, PA, and TX. Healthcare facilities and users should stop using these specific lots and contact Synthes (USA) Products LLC for further instructions.
The recalled product
- Product
- Part # SD313.012, Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med, lot # UR75221 & UR80162, mfg 7/18/2007-8/2/2007 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
- 18
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 (4)
- Part # SD313.012
- Matrix Neuro Screwdriver Blade MQC/MR Conditional/Med
- lot # UR75221 & UR80162
- mfg 7/18/2007-8/2/2007
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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