Synthes 3.2 mm Drill Bits Recalled for Sterile Packaging Compromise
Synthes (USA) Products LLC is recalling 7,363 sterile 3.2 mm three-fluted drill bits because the protective cap may not be secured, allowing the tip to puncture 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 involves 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 7,363 units of sterile 3.2 mm three-fluted drill bits, Catalog ID # 03.010.060S. These 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; if this cap is not secured, the drill bit may puncture the sterile barrier. The affected units were distributed nationwide in the United States.
Healthcare providers and facilities should check their inventory for the specific Catalog ID and lot numbers listed in the official recall notice. If the protective cap is not secured on the drill bit tip, the sterile barrier may be compromised, posing a risk of contamination during use.
The recalled product
- Product
- 3.2 mm Three-fluted drill bit, sterile, Catalog ID # 03.010.060S Product Usage: 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…
- Manufacturer
- Synthes (USA) Products LLC
- Affected units
- 7,363
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 03.010.060S Lot # 5558809
- 6204324
- 6813586
- 7648837
- 5559839
- 6214366
- 6818438
- 7648838
- 5575915
- 6235676
- 6827807
- 7657752
- 5579717
- 6240287
- 6830470
- 7657753
- 5582298
- 6247514
- 6835634
- 7660380
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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