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 its Double Offset Rasp Handle, Left Hand Nonsterile due to complaints that the handle fails to remain assembled to the rasp during use. The failure modes include fracture of the leaf spring and other issues that cause the handle to detach from the rasp. The affected product has Item Number 82016757821 and Lot Numbers 97005188 or 97005789.
The recalled devices were distributed worldwide to the United States (in 23 states), as well as to Australia, France, Germany, Italy, Switzerland, and Canada. The source document does not specify what actions affected consumers should take regarding this recall.
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 82016757821 Lot Number 97005188, 97005789
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.