Z-0953-2015Class II

The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The...

Name: Z-0953-2015 The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The...
Creator: DePuy Orthopaedics, Inc.
Published: 2014-11-10
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2014-11-10 / Terminated / root cause: design

FDA source

DePuy Orthopaedics, Inc. began a recall of The ATTUNE INTUITION Impaction Handle is a re-useable instrument utilized in knee replacement procedures. The instrument interfaces with several related ATTUNE... on 2014-11-10. FDA classified it as Class II and gives the reason as "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...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-0953-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-10
Posted: 2015-01-12
Terminated: 2015-12-08
Recalling firm: Depuy Orthopaedics Inc.
Product: 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.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: 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.
Root cause tag: design
FDA root cause: Device Design
Action: 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).
Quantity in commerce: 7,944
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 codes and lots: CATALOG NO. : 2544-01-017 LOT NUMBER: All Lots Barcode GTIN: 10603295423324

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0953-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0953-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-21	2015-01-12

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)