Synthes (USA) Products LLC: Medical Device Recall in 2016 - (Recall #: Z-1312-2016)

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:

Synthes Interlocking Bolt, 151 mm (General and Plastics Surgery Devices) Guide, Surgical Instrument

Product Classification:

Class II

Date Initiated: February 16, 2016

Date Posted: April 6, 2016

Recall Number: Z-1312-2016

Event ID: 73600

Reason for Recall:

DePuy Synthes is initiating a voluntary medical device recall of certain lots of the Interlocking Bolt which are a part of the Synthes 4.5 mm LCP Proximal Tibia Plate System. The Synthes 4.5 mm LCP Proximal Tibia Plate are indicated for the treatment of nonunions, malunions and fractures of the proximal tibia including: simple comminuted, lateral wedge, depression, medial wedge, bicondylar, combi

Status: Terminated

Product Quantity: 42 plate systems

Code Information:

Lot Number# 1776197 (5706588), 1782340 and 1868678 Catalog ID 03.120.027 For lot 1776197, the part is etched with 1776197; the package label documents 5706588.

Distribution Pattern:

Nationwide Distribution including AL, AR, AZ, CA, CO, CT, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NJ, NV, NY, OH, OR, PA, SC, SD, TN, TX, UT, VA, WA, WI, and WV.

Voluntary or Mandated:

Voluntary: Firm initiated