Synthes (USA) Products LLC: Medical Device Recall in 2015 - (Recall #: Z-0192-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

Product Description:

Synthes Threaded Plate Holder- Long for 3.5mm Locking Hold; Part Numbers 324.031. The Threaded Plate Holder can be used as an aid to position the plate on the bone. The plate holder may also function as an insertion handle for use with minimally invasive plating techniques. The plate may be temporarily held in place with standard plate holding forceps or the push-pull reduction device.

Product Classification:

Class II

Date Initiated: October 7, 2015

Date Posted: November 4, 2015

Recall Number: Z-0192-2016

Event ID: 72360

Reason for Recall:

The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a Small Fragment Plate.

Status: Terminated

Product Quantity: 25

Code Information:

Threaded Plate Holder-Long for 3.5mm Locking Hole Part Numbers Lot Numbers 324.031 8225613

Distribution Pattern:

Worldwide distribution: US (nationwide) and country of: Canada.

Voluntary or Mandated:

Voluntary: Firm initiated