The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0199-2015·Announced 2014-11-19

DePuy ATTUNE Intuition Distal Femoral Jig Recall for Bushing Defect

DePuy Orthopaedics is recalling ATTUNE Intuition Distal Femoral Jigs because a pin bushing defect could cause the plastic to fracture or displace during use.

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 with a potential for structural failure (fracture/displacement) during use, which poses a risk of harm, but the source text does not report any actual injuries or illnesses, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.

Plain-English summary

DePuy Orthopaedics, Inc. is issuing a device correction for the ATTUNE Intuition Distal Femoral Jig. The recall affects 3,082 units sold non-sterile, which are wrapped in bubble wrap and sealed in a polyethylene bag. The products are identified by Catalog NOs. 2544-00-521 and 2544-00-520.

The recall is being issued because if the pin bushing is overloaded or inverted, there is a potential for partial or full displacement and fracture of the plastic around the pin bushing. The source text does not report any specific injuries or illnesses associated with this defect.

The affected units were distributed worldwide, including the United States (nationwide except Alaska, including Puerto Rico), Canada, Australia, and numerous other countries. Healthcare providers and facilities should inspect the specific lot numbers listed in the recall notice and swap out any units where the bushing is incorrectly assembled.

The recalled product

Product
ATTUNE Intuition Distal Femoral Jig; sold non-sterile; product is wrapped in bubble wrap and then sealed inside a polyethylene bag
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Surgical Instrument
Hazard
Affected units
3,082

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)

  • Catalog NOs. 2544-00-521 and 2544-00-520

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

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