Z-1704-2018 Class II Terminated

Recalled by DePuy Orthopaedics, Inc. — Warsaw, IN

FDA device recall Z-1704-2018 was initiated by DePuy Orthopaedics, Inc. on Apr 16, 2018 and is designated Class II. Reason for recall: There may be burrs on the extraction hole threads. The recall status is terminated (terminated Apr 2, 2019). Affected quantity: 1 unit.

Recall Details

Product Type
Devices
Report Date
May 16, 2018
Initiation Date
Apr 16, 2018
Termination Date
Apr 2, 2019
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
1 unit

Product Description

ATTUNE Revision CRS Femoral RT SZ 5 Cemented, Catalog No. 150440205, Femoral Revision Implant, Knee

Reason for Recall

There may be burrs on the extraction hole threads.

Distribution Pattern

The products were distributed to the following US states: FL, MO, and PA.

Code Information

Lot Number HD6516, GTIN Number 10603295042280

Source

Dataset
openFDA device recall enforcement reports
FDA record
This recall in openFDA (JSON)
Enforcement Report
Search FDA's Enforcement Report for Z-1704-2018
openFDA file date
Oct 23, 2026
Loaded by RegDataLab
Oct 25, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.