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FDA (Device enforcement)Recalled 2014-07-23closedclass ii

Zimmer, Inc.: Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)

Is my product affected?

Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right)

  • UPC 00780803522

Check against the official notice below — it lists the full affected range.

What happened

Zimmer, Inc. is recalling 412 units of Double Offset Rasp Handle, Right Hand A/S Rasp Handle (Right) due to a hazard where the handle may fail to remain properly assembled to the rasp during use. The failure can occur through various mechanisms, including fracture of the leaf spring that holds the handle in place. The affected product is identified by Item Number 00780803522 and Lot Numbers 56474889, 56474890, 56474895, or 56474896.

The recalled devices were distributed worldwide, including throughout the United States and in Australia, France, Germany, Italy, Switzerland, and Canada. The source document does not specify what action affected consumers should take regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

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 00780803522 Lot Number 56474889, 56474890, 56474895, 56474896

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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