The Recall Desk
Agency classClass IIOur severity:HighFDA (Devices)·Z-0074-2022·Announced 2021-10-13

ATTUNE Revision Tibial Augment recalled for packaging with incompatible screws

ATTUNE Revision Tibial Augment (5mm) packaging may include incompatible screws, potentially delaying surgery. Distributed to 10 US states.

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: This is a Class II recall of surgical implant components where incorrect packaging contents may cause surgical delay. No injuries or illnesses are reported. Per the severity rubric, this qualifies as High (Score 3) because it is a risk-of-harm product where injury has not yet been reported.

Plain-English summary

ATTUNE Revision Tibial Augment Size 7/8 5mm is a surgical component used in knee joint replacement procedures. DePuy Orthopaedics, Inc. has issued a Class II recall because packaging may include screws that are not intended for use with the 5mm augment, which may cause delay in surgery.

The affected lot (J6304Z) includes 10 units distributed nationwide to medical facilities in California, Louisiana, Minnesota, Missouri, North Carolina, Nebraska, Oregon, Pennsylvania, Washington, and Wisconsin. No injuries or illnesses have been reported.

Medical facilities and surgical teams that may have received affected units should immediately inspect package contents to ensure all components match the product specification. If incompatible screws are identified, do not use the product and contact DePuy Orthopaedics, Inc. for disposal or return instructions.

The recalled product

Product
ATTUNE Revision Tibial Augment Size 7/8 5mm- intended for knee joint replacement Part Code:152307001
Manufacturer
DePuy Orthopaedics, Inc.
Category
Medical Device — Orthopedic Implant
Hazard
Affected units
10

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 Number: J6304Z GTIN: 10603295057642

Distribution

Distributed nationwide across the United States.

The notice also names 10 states specifically:

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