Synthes Recalls 1.3mm Stardrive Screwdrivers for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 75 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: 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 or illnesses fall under the Moderate severity category.
Plain-English summary
Synthes (USA) Products LLC is voluntarily recalling 75 units of Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC. The affected units were manufactured between February 28, 2002, and June 6, 2002, and include lot numbers 4341031, 4363779, and 4427697.
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. These instruments are used to assist with the insertion or removal of implants.
The affected products 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. Healthcare facilities should verify their inventory against the specific part and lot numbers listed in this notice.
The recalled product
- Product
- Part # 313.211, 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC, lot # 4341031, 4363779, 4427697, mfg. 2/28/2002-6/6/2002 Product Usage: The DePuy Synthes MR Safe Instruments and MR conditional Instruments are used to assist with the insertion or removal of an…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 75
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 (6)
- Part # 313.211
- 1.3mm Stardrive Screwdriver Bld Slf-Retain Shrt/42mm MQC
- lot # 4341031
- 4363779
- 4427697
- mfg. 2/28/2002-6/6/2002
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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