Z-0904-2015Class II

Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments...

Name: Z-0904-2015 Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments...
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 Rotating Tibial Platform ATTUNE INTUITION Impactor. The ATTUNE INTUITION Impactors are re-useable instruments utilized in knee replacement procedures. The... on 2014-11-10. FDA classified it as Class II and gives the reason as "ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small...". 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-0904-2015
Classification: Class II
Status: Terminated
Initiated: 2014-11-10
Posted: 2015-01-05
Terminated: 2015-12-08
Recalling firm: Depuy Orthopaedics Inc.
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 its relevant mating part: Fixed Tibial bearing, (254401003) Rotating Tibial Platform, (254401004) and Femoral impactor, (254401006).
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: ATTUNE INTUITION Impactors (cat. nos. 254401003, 254401004, and 254401006) have broken and produced small pieces. Should a fracture occur and not be observed during surgery, there is the potential for these small fractured pieces of the instrument to be left in the patient.
Root cause tag: design
FDA root cause: Device Design
Action: DePuy Synthes sent an Urgent Information letter dated November 10, 2014, to all affected customers. 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. Customers were instructed to complete the Hospital/User Facility Acknowledgement Car and return to their Deputy Orthopaedics Sales Consultant or fax to 574-371-4939. Customer swere also asked to retain a copy of the complete Acknnowlegement Card in their files along with the notice. Customers with questions were instructed to call 574-371-4917 (M-F; 8 a.m. 5 p.m. EDT). For questions regarding this recall cal 574-371-4917.
Quantity in commerce: 3861
Distribution: Worldwide Distribution: US (nationwide) including P.R. except AK and RI; and Internationally to: Chile, Canada, Australia, Austria, Belgium, China, France, Ireland, India, Israel, Italy, Japan, Malaysia, Netherlands, New Zealand, Singapore, Slovakia, South Africa, South Korea, Spain, Switzerland, Thailand, United Arab Emirates (UAE), and United Kingdom (UK).
Product codes and lots: CATALOG NO. : ATTUNE INTUITION Impactors Rotating Tibial Platform, (254401004) Barcode GTIN Number: Rotating Tibial Platform, ......... 10603295130208 ALL LOTS

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0904-2015
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0903-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-05
Z-0904-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-05
Z-0905-2015	Class II	Terminated	Voluntary: Firm initiated	2015-01-14	2015-01-05

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)