FDA recall Z-1103-2021

Product

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.

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.

Key facts

Status

Terminated

Initiation date

2021-01-08

Report date

2021-02-17

Termination date

2024-01-17

Voluntary/Mandated

Voluntary: Firm initiated

Location

Warsaw, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1103-2021