DePuy Orthopaedics, Inc.: Medical Device Recall in 2021 - (Recall #: Z-1103-2021)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2021.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: January 8, 2021

Date Posted: February 17, 2021

Recall Number: Z-1103-2021

Event ID: 87189

Reason for Recall:

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

Status: Terminated

Product Quantity: 60 sleeves

Code Information:

Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92

Distribution Pattern:

Worldwide distribution - US Nationwide distribution in the states of AK, CA, FL, IN, MI, MN, MS, NC, NY, OH, PA, TX, VA and the countries of Canada, China, Germany, Puerto Rico, Switzerland.

Voluntary or Mandated:

Voluntary: Firm initiated