Universal Femoral Sleeves - Product Usage: used recall
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Why was Universal Femoral Sleeves - Product Usage: used recalled?
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Product No.: 129453216, 129453226, 129453236,129453246 Lot No.: J85Y90, J86T23, J86T20, J8790J, J85Y92
- Product
- Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
- Recalling firm
- DePuy Orthopaedics, Inc.
- 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.
- Recall date
- February 17, 2021
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)