VER2 D8L OFFSET RASP HANDLE, RT Nonsterile
Check against the official notice below — it lists the full affected range.
Zimmer, Inc. is recalling 412 units of the VER2 D8L OFFSET RASP HANDLE, RT Nonsterile due to a hazard where the handle may fail to remain properly assembled to the rasp during use. The company received complaints about the handle detaching from the rasp because of various failure modes, including fracture of the leaf spring. The affected product has Item Number 82016761302 and was distributed in lot numbers 97009564, 97009565, and 97009570.
The recalled rasps were distributed worldwide, including throughout the United States and to Australia, France, Germany, Italy, Switzerland, and Canada. The source document does not specify a remedy or instructions for what affected consumers should do 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 82016761302 Lot Number 97009564, 97009565, 97009570
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.