Synthes Recalls Surgical Handles for Incorrect MR Safety Labeling
Synthes (USA) Products LLC is recalling 29 surgical handles because their MR safety labels do 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 a voluntary precautionary action regarding labeling compliance with ASTM standards, with no reported injuries or illnesses.
Plain-English summary
Synthes (USA) Products LLC is voluntarily recalling 29 units of Part #311.039, Handle with Mini QC Small. The affected lots are 4401497, 4687440, 4687441, 5639684, 4415131, 4663839, and 5623098. These instruments are used to assist with the insertion or removal of implants.
The recall was initiated because the devices were distributed with etched or labeled 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 devices and contact Synthes (USA) Products LLC for further instructions.
The recalled product
- Product
- Part #311.039, Handle with Mini QC Small, Lot # 4401497, 4687440, 4687441, 5639684, 4415131,4663839, 5623098 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
- 29
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 (9)
- Part #311.039
- Handle with Mini QC Small
- Lot # 4401497
- 4687440
- 4687441
- 5639684
- 4415131
- 4663839
- 5623098
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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