DePuy Spine EXPEDIUM Offset Torque Wrench Recalled for Wear
DePuy Spine is recalling 140 EXPEDIUM Offset Torque Wrenches because a handle component wears prematurely, potentially causing inaccurate torque readings.
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 involves a medical device where a defect could lead to inaccurate torque readings during a surgical procedure. This represents a risk-of-harm product where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
DePuy Spine, Inc. is recalling 140 units of the EXPEDIUM Offset Torque Wrench (Product Code 2797-29-510). The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.
The recall is due to a component within the handle that is prematurely wearing. This wear may result in the instrument recording torque values outside of the specification.
The affected units were distributed nationwide in the United States and internationally to Belgium, Egypt, Ireland, Italy, Portugal, and the UK. All lots are affected. No specific instructions for consumers are provided in the source text.
The recalled product
- Product
- DePuy Spine EXPEDIUM Offset Torque Wrench Product Code 2797-29-510 The device is intended for use during the final tightening of an Expedium Offset Spinal Construct.
- Manufacturer
- DePuy Spine, Inc.
- Affected units
- 140
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)
- All lots
Distribution
Distributed nationwide across the United States.
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