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Synthes (USA) Products LLC recalls 3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression
Recalled October 31, 2018 · FDA recall Z-0238-2019 · Synthes (USA) Products
Hazard
The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length. · FDA Class II
Units
20
Sold at
US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX.
Description
The product inside the package does not match the label. The product was labeled as long thread screws that have a 6mm thread length but were actually short thread screws with a 4mm thread length.
Product
3.0mm Headless Compression Screw, Long Thread 18mm, Part Number 04.226.118 DePuy Synthes 3.0mm Headless Compression Screws are intended for fixation of intra-articular and extra-articular fractures and nonunions of small bones and small bone fragments.
Manufacturer(s)
Synthes (USA) Products LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →