Double Offset Rasp Handle, Left Hand Nonsterile
Check against the official notice below — it lists the full affected range.
Zimmer, Inc. is recalling the Double Offset Rasp Handle, Left Hand Nonsterile due to a hazard where the handle can fail to remain assembled to the rasp during use. The company received complaints about various failure modes, including fracture of the leaf spring that holds the components together. The recalled product has Item Number 82016757831 and includes Lot Numbers 97008287, 97900066, 97900084, 97900106, and 97900158. A total of 412 units were distributed worldwide.
The affected product was distributed throughout the United States in multiple states including California, New York, Texas, Florida, and others, as well as 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 82016757831 Lot Number 97008287, 97900066, 97900084, 97900106, 97900158
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.