Synthes USA HQ, Inc.: Medical Device Recall in 2013 - (Recall #: Z-0390-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2013.

Data Source: FDA.

Product Description:

3.7mm and 5.0mm Dynamic Locking Screw (DLS) Product Usage: 3.7mm and 5.0mm Dynamic Locking Screw (DLS) in combination with Synthes Locking Compression Plates (LCP) are intended for use in long bone fractures, the fixation of osteopenic bone, the fixation of osteotomies, and for the fixation of non-unions and malunions.

Product Classification:

Class II

Date Initiated: July 22, 2013

Date Posted: December 4, 2013

Recall Number: Z-0390-2014

Event ID: 66666

Reason for Recall:

All lots of 3.7mm and 5.0mm Dynamic Locking Screw (DLS) were recalled due to complaints of breakages at the distal tip of the pin identified after successful healing and during planned removal of the device.

Status: Terminated

Product Quantity: 40248

Code Information:

All lots of parts 09.213.022S - 09.213.070S, and 09.223.032S- 09.223.090S.

Distribution Pattern:

Worldwide Distribution - USA (nationwide) and internationally to Canada.

Voluntary or Mandated:

Voluntary: Firm initiated