Synthes Recalls 2.0mm Stardrive Screwdriver for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 36 units of 2.0mm 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 a labeling error (MR safety information not meeting ASTM standards) with no reported injuries or illnesses, fitting the criteria for a Moderate severity score.
Plain-English summary
Synthes (USA) Products LLC is voluntarily recalling 36 units of Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC. The affected units are from lot # 4363820, manufactured on September 11, 2002. These 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 products 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 and consumers should stop using the affected instruments and contact Synthes (USA) Products LLC for further instructions.
The recalled product
- Product
- Part # 313.232, 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC, lot # 4363820, mfg. 9/11/2002 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
- 36
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 # 313.232
- 2.0mm Stardrive Screwdriver Bld Slf-Retain Med/66mm MQC
- lot # 4363820
- mfg. 9/11/2002
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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