Recall Z-0787-2016— DePuy Orthopaedics, Inc.
Class II · Terminated
Class II FDA medical device recall by DePuy Orthopaedics, Inc., initiated 2016-01-08, terminated 2017-03-24. FDA's recall record names no specific 510(k) clearance for this event. Product: SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.. Reason: 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..
- Recalling firm
- DePuy Orthopaedics, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-01-08
- Terminated
- 2017-03-24
- Firm location
- Warsaw, IN, United States
Product description
SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.