Exactech Articulated Driver Recalled for Potential Disassembly During Use
Exactech, Inc. is recalling 57 Articulated Driver units because the cross pin may shift out of position, potentially leading to instrument disassembly during orthopedic surgery.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a risk-of-harm product (potential disassembly during surgery) where no specific injuries or illnesses have been reported in the source text.
Plain-English summary
Exactech, Inc. is recalling 57 units of the Exactech Articulated Driver, a nonpowered hand-held device intended for medical purposes to manipulate tissue or for use with other devices in orthopedic surgery. The recall is due to a defect where the cross pin may shift out of position when torque is applied to the device at the maximum angle. This shift can potentially lead to the disassembly of the instrument.
The affected units are identified by Lot # 52667001 and Catalog # 181-00-04. These devices were distributed in the United States, specifically in the states of Arkansas, California, Florida, New Jersey, New York, Oklahoma, and Texas.
Healthcare facilities and users should stop using the affected Articulated Driver units immediately. Exactech, Inc. is the recalling firm responsible for managing this Class II recall.
The recalled product
- Product
- Exactech Articulated Driver A nonpowered hand-held device intended for medical purposes to manipulate tissue, or for use with other devices in orthopedic surgery.
- Manufacturer
- Exactech, Inc.
- Affected units
- 57
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 (1)
- Lot #: 52667001 Catalog #: 181-00-04
Distribution
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