Z-1703-2018Class II

ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee

Name: Z-1703-2018 ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
Creator: DePuy Orthopaedics, Inc.
Published: 2018-04-16
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2018-04-16 / Terminated / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee on 2018-04-16. FDA classified it as Class II and gives the reason as "There may be burrs on the extraction hole threads". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1703-2018
Classification: Class II
Status: Terminated
Initiated: 2018-04-16
Posted: 2018-04-30
Terminated: 2019-04-02
Recalling firm: Depuy Orthopaedics Inc.
Product: ATTUNE Revision CRS Femoral LT SZ 5 Cemented, Catalog No. 150440105, Femoral Revision Implant, Knee
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: There may be burrs on the extraction hole threads.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Notification letters distributed on 4/17/18 instructed customers to perform the following: Steps to Take Please take the following actions: " Immediately return unused affected units: Note: On March 19, 2018, one unit was removed from consignment. Two units were implanted prior to the medical device recall. No additional units are in the market. " Reconciliation Form: Complete the reconciliation form and return to your sales consultant or fax to 574-371-4939 or email to [email protected] within five (5) days of this notice. " Records: Retain a copy of the completed reconciliation form in your files along with this notice. " Additional Notifications: o Notify surgeons at your facility by providing them with a copy of this notice. Forward this notice to others in your facility that need to be informed. Clinical Implications and Patient Impact DePuy (Ireland) is not recommending prophylactic revision in the absence of symptoms. The company recommends that surgeons discuss potential clinical implications and risks with symptomatic patients that received the affected units.
Quantity in commerce: 2 units
Distribution: The products were distributed to the following US states: FL, MO, and PA.
Product codes and lots: Lot Number HC1179, GTIN Number 10603295042181; Lot Number HC1183, GTIN Number 10603295042181

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1703-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1703-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-07
Z-1704-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-16	2018-05-07

Product code JWH

K160700Class IIATTUNE Revision Knee SystemDepuy(Ireland) / cleared 2016-06-10

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)