Recall Z-0400-2013 ยท HWT Template
Zimmer, Inc.
00780304001 MIS 12/14 Slotted Femoral Head Provisional -3.5X36 00780304002 MIS 12/14 Slotted Femoral Head Provisional +0X36 00780304003 MIS 12/14 Slotted Femoral Head Provisional +3.5X36 00780304004 MIS 12/14 Slotted Femoral Head Provisional +7X36 00780304005 MIS 12/14 Slotted Femoral Head Provisional +10.5X36 The provisional heads replicate final femoral implant geometry and are used to trial ran
| Date | Nov 19, 2012 (initiated Oct 10, 2010) |
| Status | Terminated |
| Reason | Surgical technique instructions for the Versys and Slotted Provisional Femoral Heads have been enhanced to inform users that the head may become difficult to visually locate if it becomes displaced deep or medial to the iliopsoas tendon and provide non-invasive imaging methods that can be used to locate the head. To reduce incidence of sub-optimal fit between provisional femoral heads and the mat |
| Root cause | Device Design |
| Action | The firm, Zimmer, sent notification by email to consignees beginning October 10, 2012 with a follow-up letter titled "URGENT MEDICAL DEVICE CORRECTION" dated October 16, 2012 to its consignees/customers. The letter described the product, problem and actions to be taken. The customers were instructed to complete a spreadsheet of current users and contact information and immediately provide this information via email to: CorporateQuality.Postmarket@zimmer.com, and review and become familiar with the content and recommendations of the attached letter sent to the customers. For questions |
| Quantity | 56,516 all lots, all sizes |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Asia, Barbados, Canada, Europe, Mexico, Puerto Rico, San Juan, and South America. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.