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 82016757931, Lot Number 97009560) due to a hazard where the handle fails to remain assembled to the rasp during use. The firm received complaints about various failure modes, including fracture of the leaf spring, which caused the handle to separate from the rasp.
The affected product was distributed worldwide, including throughout the United States and in Australia, France, Germany, Italy, Switzerland, and Canada. The source does not specify a remedy for consumers who possess 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 82016757931 Lot Number 97009560
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.