FDA recall Z-0238-2019

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.

Reason for recall

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.

Distribution

US Distribution to the following states: AR, AZ, FL, IL, NM, OH, and TX.

Key facts

Status

Terminated

Initiation date

2018-09-12

Report date

2018-10-31

Termination date

2020-04-10

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0238-2019