Synthes (USA) Products LLC: Medical Device Recall in 2015 - (Recall #: Z-0024-2016)

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 Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates

Product Classification:

Class II

Date Initiated: September 14, 2015
Date Posted: October 14, 2015
Recall Number: Z-0024-2016
Event ID: 72238
Reason for Recall:

Affected lots of Periarticular Aiming Arms and Insertion Handles (Part Numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm LCP Proximal Tibia Plates are not able to be secured to the subsequent versions of these devices as intended.

Status: Terminated
Product Quantity: 172
Code Information:

Part Numbers: 03.120.005 03.120.004 03.120.002 03.120.001 with Lot Numbers: 1780076; 1797331; 1829300 1789754; 1802319; 1810706; 1810707; 5704446 1780074; 1829294; 1829296 1789751; 1802318; 1810704; 1810705; 1828749; 1879604

Distribution Pattern:

Nationally

Voluntary or Mandated:

Voluntary: Firm initiated