Recall Z-0023-06 ยท KWS Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented
Zimmer Inc.
Zimmer brand Bigliani/Flatow Total Shoulder trabecular metal glenoid component, 40 mm dia. articular surface, small, sterile, for cemented use only in the USA, Cat. no. 00430604000.
| Date | Oct 7, 2005 (initiated Aug 23, 2005) |
| Status | Terminated |
| Reason | The implant may fracture at the junction of the base and the trabecular metal keel if adequate support for the base has not been achieved by the host bone and/or bone cement. |
| Root cause | Other |
| Action | Consignees were notified via letter dated August 23, 2005 or by email. |
| Distribution | Nationwide, Australia, Canada, England, Germany and Italy. |
| FDA record | Open on fda.gov |