Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-1949-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

LCP Dia-Meta Volar Distal Radius Plate 15 H Shaft/LT-Sterile; Indicated for fractures, osteotomies, and non-unions of the radius and other small bones.

Product Classification:

Class II

Date Initiated: May 2, 2016

Date Posted: June 22, 2016

Recall Number: Z-1949-2016

Event ID: 74082

Reason for Recall:

Product incorrectly packaged. The labels on the outside of the box and on the LCP Dia-Meta Volar Distal Radius Plate inside the box are correct; however, the preprinted box which contains the LCP-Dia-Meta Volar Distal Radius Plate is incorrect. The box is preprinted for a 4.5 mm LCP Condylar Plate - Distal Femur.

Status: Terminated

Product Quantity: 6 units

Code Information:

Lot Number 9890811, Catalog ID 02.110.115S

Distribution Pattern:

Distributed to one customer: Colorado

Voluntary or Mandated:

Voluntary: Firm initiated