VI DBL OFFST W/ LRG STPL, LT Nonsterile
Check against the official notice below — it lists the full affected range.
Zimmer, Inc. is recalling 412 units of its VI DBL OFFST W/ LRG STPL, LT Nonsterile surgical rasp due to a hazard where the handle may fail to remain assembled to the rasp during use. The company received complaints about handle separation caused by various failure modes, including fracture of the leaf spring. The affected product has Item Number 82016757841 and Lot Numbers 97009219 or 97009254.
The recalled rasps were distributed worldwide, including throughout the United States in multiple states and internationally in Australia, France, Germany, Italy, Switzerland, and Canada. The source document does not specify a remedy or instructions for what 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 82016757841 Lot Number 97009219, 97009254
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.