Z-1103-2021Class II

Universal Femoral Sleeves -

Name: Z-1103-2021 Universal Femoral Sleeves -
Creator: DePuy Orthopaedics, Inc.
Published: 2021-01-08
License: https://open.fda.gov/license/

Depuy Orthopaedics Inc. / initiated 2021-01-08 / Terminated / root cause: manufacturing process

FDA source

DePuy Orthopaedics, Inc. began a recall of Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products on 2021-01-08. FDA classified it as Class II and gives the reason as "The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots". 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-1103-2021
Classification: Class II
Status: Terminated
Initiated: 2021-01-08
Posted: 2021-02-09
Terminated: 2024-01-17
Recalling firm: Depuy Orthopaedics Inc.
Product: Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Product code: JWH Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Reason for recall: The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Root cause tag: manufacturing process
FDA root cause: Nonconforming Material/Component
Action: On 01/12/2021, DePuy Synthes issued an Urgent Medical Device Recall (removal) via letter due to taper dimensions of certain Universal Femoral Sleeves may be out of specification. The Universal Femoral Sleeves are used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products. DePuy is recommending that customers return the recalled devices.
Quantity in commerce: 60 sleeves
Distribution: 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.
Product codes and lots: Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1103-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1103-2021	Class II	Terminated	Voluntary: Firm initiated	2021-02-17	2021-02-09

Product code JWH

K063633Class IIDepuy Knee Prosthesis System Universal Stem Extensions and Femoral Metaphyseal SleevesDePuy Orthopaedics, Inc. / cleared 2007-03-02

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)