Recall Z-1512-2018 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Howmedica Osteonics Corp.
Knee Prosthesis, Sterile, Single-Use devices Product Usage: The knee system devices are intended for use in revision total knee arthroplasty to alleviate pain and restore function
| Date | Jan 12, 2018 |
| Status | Terminated |
| Reason | Firm became aware that the specific product/lot combinations referenced above may contain the incorrect size implant from what is labeled on the box. |
| Root cause | Error in labeling |
| Action | Branches/Agencies notified by email on 01/16/2018 and were asked to quarantine affected devices. Notification letters and product accountability forms were sent via UPS (with return receipt) on 01/15/2018. Customer notifications were updated and sent to consignees on 03/16/2018 as the technical and medical assessments associated with the issue were completed and additional information related to potential hazards and harms were identified. |
| Quantity | 6 units of catalog 5521-B-400 |
| Distribution | Affected products were sent to three medical facilities. Affected product will be returned to the manufacturer for disposition. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K141056 | TRIATHLON KNEE SYSTEM POSTERIOR STABILIZED COMPONENTS Stryker Orthopaedics, Aug 5, 2014 |