Drug recall

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

FDA recall event 72238 · Class II · Synthes (USA) Products LLC

Key facts

Event ID 72238
Recall numbers Z-0024-2016
Recalling firm Synthes (USA) Products LLC
Product type Devices
Products Synthes Periarticular Insertion Handle for 4.5mm LCP Proximal Tibia Plates and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates
Classification Class II
Status Terminated
Voluntary or mandated Firm Initiated
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…
Initiation date Sep 14, 2015
Report date Oct 14, 2015
Termination date Jul 15, 2016
City West Chester
State PA
Country United States
FEI number 3008812560

At a glance

  • 1–9 Products in this recall
  • 1–9 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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