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
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Brand
DePuy Orthopaedics, Inc.
Lot Codes / Batch Numbers
Product No.: 129453216, 129453226, 129453236, 129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92
Products Sold
Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92
DePuy Orthopaedics, Inc. is recalling Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noile due to The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026