SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during tri

FDA device recall Z-0787-2016 · posted 2016-02-09 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

Increased punch height, causing a 0.063 in (1.6 mm) gap between the trial and the instrument. This may cause the surgeon to select an insert that is too thin. Surgical delay may result if the punch dislodges from the inserter and needs to be removed from the joint space. Insert Dislocation or Spin Out, or Poor Joint Mechanics may result, if not noted during surgery. May require revision surgery.

Action taken

On 1/8/2016, URGENT INFORMATION RECALL NOTICE for Specific Lots of SIGMA High Performance (HP) MBT Non-Keel Punch Knee Instrument notifications were sent to the affected distributors and Medical Professionals with instructions for identifying and returning the affected product. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. For clinical questions from surgeons, please contact DePuy Orthopaedics, Inc.s Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. 5 p.m. EDT). For questions about the device recall information provided, please contact Kim Earle, Senior Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. 5 p.m. EDT).

Root cause

Component design/selection

Status

Terminated

Product code

LRY

Quantity affected

351

Distribution

Worldwide Distribution-US Nationwide, Armenia, Australia, Austria, Belgium, Czech Republic, Denmark, Egypt, France, Germany, Greece, Hungary, India, Ireland, Israel, Italy, Japan, Luxembourg, Malaysia

Date initiated

2016-01-08

Date posted

2016-02-09

Date terminated

2017-03-24

Location

Warsaw, IN