VER2 DBL OFFSET RASP HANDLE, LT Nonsterile
Check against the official notice below — it lists the full affected range.
Zimmer, Inc. is recalling 412 units of the VER2 DBL OFFSET RASP HANDLE (Nonsterile, Item Number 82016761201) distributed worldwide across the United States, Australia, France, Germany, Italy, Switzerland, and Canada. The recall was initiated because the handle can fail to remain properly assembled to the rasp during use, with failure modes including fracture of the leaf spring. The affected product was distributed in lot numbers 97009494, 97009561, and 97009569.
The source does not specify what remedy is available to 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 82016761201 Lot Number 97009494, 97009561, 97009569
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.