FDA Medical Device Recalls (openFDA)
DePuy Orthopaedics, Inc.: Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
- Recall number
- Z-1103-2021
- 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.
- Status
- Terminated
- Initiated
- 2021-01-08
- Posted
- not on file
- Terminated
- 2024-01-17
- Reason
- The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
- 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
- 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.
- Lot, serial or model codes
- Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92
- 510(k) numbers
- ["K063633"]
- PMA numbers
- not on file
- Product code
- JWH
- Firm FEI
- 1818910
- Firm city
- Warsaw
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28