DePuy ATTUNE INTUITION Impactors Recalled Due to Fracture Risk
DePuy Orthopaedics is recalling ATTUNE INTUITION Impactors because they may break during knee surgery, potentially leaving small fragments in the patient.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall involves a medical device defect (fracture) that can result in foreign material being left in a patient during surgery, which constitutes a significant injury risk and aligns with the 'Severe' criteria for significant injury reports or structural defects.
Plain-English summary
DePuy Orthopaedics, Inc. is recalling the ATTUNE INTUITION Impactors (catalog numbers 254401003, 254401004, and 254401006). These are reusable instruments used in knee replacement procedures to impact and drive home specific mating parts, including the Fixed Tibial bearing, Rotating Tibial Platform, and Femoral impactor.
The recall is due to reports that the impactors have broken and produced small pieces. If a fracture occurs during surgery and is not observed, there is a potential for these small fractured pieces of the instrument to be left in the patient.
The affected units were distributed worldwide, including the United States (nationwide, including Puerto Rico, excluding Alaska and Rhode Island) and various international markets. Healthcare facilities and providers should stop using these instruments and contact DePuy Orthopaedics for instructions on return or replacement.
The recalled product
- Product
- Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The three affected impactors are used at various times within the surgical flow, each impactor is used to impact and drive home…
- Manufacturer
- DePuy Orthopaedics, Inc.
- Hazard
- Affected units
- 3,861
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 (3)
- CATALOG NO. : ATTUNE INTUITION Impactors Rotating Tibial Platform
- (254401004) Barcode GTIN Number: Rotating Tibial Platform
- ......... 10603295130208 ALL LOTS
Distribution
Part of a larger recall action
This product is one of 3 recalled by DePuy Orthopaedics, Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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