ATTUNE recallZ-0953-2015 · DePuy Orthopaedics, Inc. · initiated Nov 10, 2014
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from DePuy Orthopaedics, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Complaints have indicated that the ATTUNE INTUITION Impaction Handle lever has fractured during impaction. If the lever fractures, there is the potential for fractured pieces of the device, or the inner spring, if released, to be left in the patient if not observed during surgery.
FDA root cause category: Device Design
What the company is doing
On 11/10/2014, URGENT INFORMATION ATTUNE INTUITION IMPACTION HANDLE AND IMPACTORS DEVICE CORRECTION NOTICE notifications were sent to the affected distributors and medical professionals. All distributors were notified via electronic mail, and all medical professionals with affected inventory were also notified by distributor or Sales Consultant via in person delivery or mail or electronic mail. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For questions, please contact Kim Earle, Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT).
Recall details
- Recall number
- Z-0953-2015
- Status
- Terminated
- Initiated by the company
- Nov 10, 2014
- Posted by the FDA
- Jan 12, 2015
- Recalling firm
- DePuy Orthopaedics, Inc.
- Quantity
- 7,944
- Product code
- LXH
- Distribution
- Worldwide Distribution-US (nationwide) except AK and RI, including PR and the countries of Chile, Canada, Australia, Austria, Belgium, France, Hong Kong, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Saudi Arabia, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK
Product description
The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE instruments: keel punch, tibial tower, evaluation bullet, fixed bearing tibial impactor, rotating platform tibial impactor, and femoral impactor, for the purpose of impaction, extraction, and insertion applications at steps within the surgical procedure. Due to the frequency of its use, two impaction handles are supplied in each kit.
Code information (models, lots, serial numbers)
CATALOG NO. : 2544-01-017 LOT NUMBER: All Lots Barcode GTIN: 10603295423324
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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