Recall Z-1103-2021— DePuy Orthopaedics, Inc.

Name: FDA recall Z-1103-2021
Creator: U.S. Food and Drug Administration
Published: 2021-01-08

Class II · Terminated

Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2021-01-08, terminated 2024-01-17. It names one FDA 510(k) clearance: K063633. Product: Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.. Reason: The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots..

Recalling firm: DePuy Orthopaedics, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-01-08
Terminated: 2024-01-17
Firm location: Warsaw, IN, United States

510(k) clearances named in this recall

1 on FDA's record

K063633 — DEPUY KNEE PROSTHESIS SYSTEM UNIVERSAL STEM EXTENSIONS AND FEMORAL METAPHYSEAL SLEEVESDePuy Orthopaedics, Inc.·cleared 2007-03-02

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.

Reason for recall

The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.

Data sourced from openFDA. This site is unofficial and independent of the FDA.