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 its Double Offset Rasp Handle, Right Hand Nonsterile due to a hazard where the handle may fail to remain assembled to the rasp during use. The company received complaints reporting various failure modes, including fracture of the leaf spring, which caused the handle and rasp to separate during use. The affected product has Item Number 82016757932 and one of the following lot numbers: 97008288, 97900067, 97900085, 97900107, or 97900157.
The recalled devices were distributed worldwide, including throughout the United States and in Australia, France, Germany, Italy, Switzerland, and Canada. The source document does not specify a remedy or recommended action for consumers who may have this product.
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 82016757932 Lot Number 97008288, 97900067, 97900085, 97900107, 97900157
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.