Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
This recall has been terminated (originally issued January 8, 2021).
- Company
- Depuy Orthopaedics, Inc.
- Recall Initiated
- January 8, 2021
- Terminated
- January 17, 2024
- Recall Number
- Z-1103-2021
- Quantity
- 60 sleeves
- Firm Location
- Warsaw, IN
- Official Source
- View on FDA website ↗
Reason for Recall
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
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 / Code Info
Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92
Root Cause
Nonconforming Material/Component
Action Taken
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.