Double Offset Rasp Handle, Right Hand Nonsterile
Check against the official notice below — it lists the full affected range.
Zimmer, Inc. is recalling 412 units of the Double Offset Rasp Handle, Right Hand Nonsterile due to a hazard where the handle fails to remain assembled to the rasp during use. The failure occurs through various modes, including fracture of the leaf spring. The affected product is identified by Item Number 82016757922 with Lot Numbers 97005189 and 97005833.
The recalled devices were distributed worldwide, including nationwide distribution across multiple U.S. states (Alaska, Alabama, Arizona, California, Colorado, Florida, Georgia, Indiana, Kansas, Kentucky, Michigan, Minnesota, North Carolina, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Dakota, Tennessee, Texas, Utah, and Virginia), as well as Australia, France, Germany, Italy, Switzerland, and Canada. The source does not specify a remedy or what affected consumers should do.
Written by software from the official notice below. Not reviewed by a lawyer.
The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring.
Reason for recall: The firm received complaints for failure of the handle to remain assembled to the rasp during use due to various failure modes, including fracture of the leaf spring. Distribution: Worldwide Distribution-USA (nationwide) including the states of AK, AL, AZ, CA, CO, FL, GA, IN, KS, KY, MI, MN, NC, NJ, NY, OH, OK, OR, PA, SD, TN, TX, UT, and VA, and the countries of Australia, France, Germany, Italy, Switzerland, and Canada. Quantity: 412 units Lot/code info: Item Number 82016757922 Lot Number 97005189, 97005833
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.