KLS E-Coupling Adapter Recalled for Incorrect Product Identifier Code
Pro-Dex Inc is recalling 199 KLS E-Coupling Adapter devices due to incorrect Unique Device Identifier (UDI) and GTIN codes. The devices were distributed nationwide.
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: This is an FDA Class II recall involving a product identification and labeling error (incorrect UDI/GTIN codes) with no reported injuries, illnesses, or functional device defect. Per the severity rubric, Class II recalls with minor labeling errors and no reported harm are scored as Moderate.
Plain-English summary
Pro-Dex Inc is recalling 199 KLS E-Coupling Adapter devices (Reference Number PDEC-1000-2, Part Number A9671) due to incorrect Unique Device Identifier (UDI) and GTIN codes on the products. The E-Coupling Adapter Assembly is used to connect KLS drivers (such as surgical drills) to driver bits that fit into the adapter, typically in orthopedic surgical settings.
The affected devices bear Lot Numbers K0C1B, K0D3P, K0E8T, K0FSD, and K0HGV and were distributed nationwide.
This is an FDA Class II recall. Healthcare facilities and practitioners in possession of the affected devices should contact Pro-Dex Inc or the FDA for further instructions.
The recalled product
- Product
- KLS martin Group KLS E-COUPLING ADAPTER REF PDEC-1000-2 E-Coupling Adapter Assembly used to connect the KLS driver (e.g. drill) to a driver bit that fits into the adapter.
- Manufacturer
- Pro-Dex Inc
- Hazard
- Affected units
- 199
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 (5)
- Reference Number: PDEC-1000-2 Part Number: A9671 Lot Numbers: K0C1B
- K0D3P
- K0E8T
- K0FSD
- K0HGV
Distribution
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