Synthes (USA) Products LLC: Medical Device Recall in 2018 - (Recall #: Z-0238-2019)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class II

Date Initiated: September 12, 2018

Date Posted: October 31, 2018

Recall Number: Z-0238-2019

Event ID: 81152

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.

Status: Terminated

Product Quantity: 20

Code Information:

Lot Numbers: L734474

Distribution Pattern:

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

Voluntary or Mandated:

Voluntary: Firm initiated