Synthes Recalls 34 Stardrive Screwdrivers for MR Safety Labeling Errors
Synthes (USA) Products LLC is recalling 34 units of 1.3mm Stardrive Screwdrivers 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: This is a voluntary precautionary recall involving labeling errors regarding MR safety standards. The source text does not report any illnesses, injuries, or deaths, and the hazard is related to documentation/labeling compliance rather than a direct physical defect causing immediate harm.
Plain-English summary
Synthes (USA) Products LLC is voluntarily recalling 34 units of Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, manufactured on 9/18/2002. These medical instruments are used to assist with the insertion or removal of implants.
The recall was initiated because the affected devices were distributed, etched, and/or labeled with MR Safety information that does not meet the current ASTM standard. The agency has classified this as a Class II recall.
The devices were distributed nationwide in the states of AR, CA, CO, CT, DC, ID, IL, KY, LA, MA, MD, MN, MO, MS, MT, NY, PA, and TX. Healthcare facilities should check their inventory for this specific part number and lot number and contact the manufacturer for instructions on how to return the devices.
The recalled product
- Product
- Part # 313.212, 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC, Lot # 4363780, mfg. 9/18/2002 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
- 34
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 # 313.212
- 1.3mm Stardrive Screwdriver Bld Slf-Retain Med/60mm MQC
- Lot # 4363780
- mfg. 9/18/2002
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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