Recall Z-1076-2007 ยท ISY Joint, Knee, External Limb Component
Ossur
Ossur Total Knee Model Number 2100, external knee prosthesis.
| Date | Jul 12, 2007 (initiated Apr 2, 2007) |
| Status | Terminated |
| Reason | Some units of the Total Knee Model 2100 produced from August 1, 2006 through October 4, 2006 may contain a faulty linkage component. |
| Root cause | Other |
| Action | On 4/2/07 a letter was mailed to all affected customers via certified mail, return receipt requested. All mailing will be followed by telephone calls from an Ossur Customer Service Representative. Customers were notified that Ossur will replace the affected knees with units carrying a two-year warranty from the date of replacement. Ossur will undertake a sub-recall by notifying the one affected distributor by letter on 4/2/07. Ossur will follow up with this distributor by telephone and request a list of consignees that the distributor sold the product to so that Ossur can directly contact |
| Quantity | 44 |
| Distribution | Nationwide. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.