Recall Z-1031-2016 ยท NPJ Prosthesis, Knee Patellofemorotibial, Partial, Semi-Constrained, Cemented, Polymer/Metal/Polymer
Mako Surgical Corporation
Restoris Multicompartmental Knee (MCK) System RESTORIS MCK is indicated for single or multi-compartmental knee replacement used in conjunction with RIO.
| Date | Jan 15, 2016 |
| Status | Terminated |
| Reason | Reports where the Mylar/Tyvek pouch for RESTORIS MCK Baseplate in the clamshell packaging configuration exhibited damage, compromising the sterile barrier. |
| Root cause | Unknown/Undetermined by firm |
| Action | The firm, Stryker Orthopaedics, sent an "Urgent Product Recall" letter dated 1/15/2016 to all their consignees. The letter described the product, problem and actions to be taken. The consignees were instructed to inspect the device packaging as the damage to the sterile barrier may be notice prior to the procedure; do not use the device if the seal or package is breached and complete and return the attached Product Recall Acknowledgment Form within 5 days by e-mail StrykerOrtho5317@Stericycle.com or fax at: 888-480-2853. Return all affected products available at your location to: Stryker c/o S |
| Quantity | 146 |
| Distribution | Worldwide Distribution: US (nationwide) including states of: AL, AZ, CA, CO, CT, FL, GA, IA, ID, IL, LA, MI, MS, MO, NC, NH, NJ, NV, NY, OH, OK, OR, PA, RI, TN, TX, UT, VA, WA, WI, and WY ; and countries of: Italy, Scotland, Turkey, Greece, Germany, and Singapore. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090763 | RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM Mako Surgical Corporation, Jun 17, 2009 |