Synthes Recalls 1.5mm Stardrive Screwdrivers for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 383 units of 1.5mm Stardrive Screwdrivers because their MR Safety information does not meet current ASTM standards.
What this means for you
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. No injuries or illnesses are reported, and the hazard is related to compliance with safety standards rather than an immediate physical defect causing harm.
Plain-English summary
Synthes (USA) Products LLC is voluntarily recalling 383 units of Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC. The affected devices were manufactured between February 12, 2002, and May 23, 2005, and are identified by specific lot numbers including 4341033, 4589566, and 4703774.
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. These instruments are used to assist with the insertion or removal of implants.
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 stop using the affected devices and contact Synthes (USA) Products LLC for further instructions.
The recalled product
- Product
- Part #313.221, 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341033, 4589566, 4703774, 4363781, 4589567, 4793575, 4904305, 4427700,4589568, 4830581, 4532370, 4673943, 4871657, mfg. 2/12/2002-5/23/2005 Product Usage: The DePuy Synthes MR Safe Instruments an
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 383
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 (16)
- Part #313.221
- 1.5mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC
- lot # 4341033
- 4589566
- 4703774
- 4363781
- 4589567
- 4793575
- 4904305
- 4427700
- 4589568
- 4830581
- 4532370
- 4673943
- 4871657
- mfg. 2/12/2002-5/23/2005
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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