Synthes 3.2 mm Radiolucent Drill Bits Recalled for Sterile Packaging Compromise
Synthes (USA) Products LLC is recalling 1,274 sterile 3.2 mm radiolucent drill bits because the protective cap may not be secured, risking puncture of the sterile barrier.
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 the hazard is a potential sterile barrier breach without reported injuries or illnesses, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Synthes (USA) Products LLC is recalling 1,274 units of 3.2 mm three-fluted radiolucent drill bits with needle points and 145 mm lengths. These sterile instruments are used with various orthopedic nailing systems, including the Expert Lateral Femoral Nail, Expert Tibial Nail, and Expert Humeral Nailing systems.
The recall is due to a potential compromise in the sterile packaging. A protective cap is required to be secured on the tip of the drill bit to prevent it from puncturing the sterile barrier. If the protective cap is not secured, the drill bit may puncture the sterile barrier, potentially compromising the sterility of the instrument.
The affected products were distributed nationwide in the United States, including the District of Columbia and 48 states. The specific catalog ID is 03.010.100S, and the recall covers multiple lot numbers. Healthcare facilities and distributors should check their inventory for these specific lot numbers and stop using the affected products.
The recalled product
- Product
- 3.2 mm three-fluted Radiolucent Drill Bit/Needle Point/145 mm Sterile Product Usage: The 3.2 mm Three-fluted Drill Bits are instruments that can be used with the following systems: Expert Lateral Femoral Nail (part number 03.010.060S only), Expert Tibial Nail, Expert Humeral…
- Manufacturer
- Synthes (USA) Products LLC
- Hazard
- Affected units
- 1,274
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 (20)
- Catalog ID 03.010.100S Lot # 5525872
- 6153368
- 6530901
- 5548707
- 6197315
- 6581051 5575918
- 6199232
- 6676406
- 5603463
- 6231850
- 6721724 5649117
- 6256560
- 6734876
- 5668880
- 6305842
- 6808463 5724639
- 6319050
- 6831468
- 5742276
- 6320150
Distribution
Part of a larger recall action
This product is one of 2 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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