FDAJuly 26, 2017device

2.5 mm Reaming Rod, Ball tip, 950 mm, sterile, Part Number: 351.706S Reaming Rods are intended for guiding of reamers during orthopedic surgery.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

What to do

FDA enforcement status: Terminated

Brands named

synthes usa productssynthessynthes usa

UPCs

2017202601312017202602282017202603312017202604302017202604302

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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