Recall Z-0787-2016 ยท LRY Punch, Surgical
DePuy Orthopaedics, Inc.
SIGMA HP MBT Non-Keel Punch Knee Instrument. Designed to be used as an option in stabilizing the tibial trial during trial reduction.
| Date | Feb 9, 2016 (initiated Jan 8, 2016) |
| Status | Terminated |
| 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. |
| Root cause | Component design/selection |
| Action | 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 |
| Quantity | 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, Netherlands, New Zealand, Norway, P R China, Portugal, Poland, Russia, Singapore, Slovenia, South |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.