Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Reported: February 17, 2021 Initiated: January 8, 2021 #Z-1103-2021
Product Description
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.
Reason for Recall
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Details
- Recalling Firm
- DePuy Orthopaedics, Inc.
- Units Affected
- 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.
- Location
- Warsaw, IN
Frequently Asked Questions
What product was recalled? ▼
Universal Femoral Sleeves - Product Usage: used primarily in revision surgeries with the S-ROM Noiles, LPS, SIGMA, and LCS Knee products.. Recalled by DePuy Orthopaedics, Inc.. Units affected: 60 sleeves.
Why was this product recalled? ▼
The taper dimensions may be out of specification due to a production issue during the manufacturing of these lots.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on February 17, 2021. Severity: Moderate. Recall number: Z-1103-2021.
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