Double Offset Rasp Handle, Left 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, Left Hand Nonsterile (Item Number 82016757830, Lot Number 97009559) due to a hazard where the handle fails to remain assembled to the rasp during use. The failure can occur through various modes, including fracture of the leaf spring. The product was distributed worldwide across the United States, Australia, France, Germany, Italy, Switzerland, and Canada.
The recall notice does not specify a remedy for consumers who 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 82016757830 Lot Number 97009559
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.