Recall Z-2094-2013 ยท KTT Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component
Zimmer, Inc.
VERSA-FX II FEMORAL FIXATION SYSTEM COMPRESSION TUBE/PLATE, standard and short - low profile, different hole/length combinations (4/86, 5/102 and 6/118), different degree angles (130, 135, 140, 145 and 150). Item codes starting with 00-194-130, 00-1194-135, 00-1194-140, 00-1194-145, 00-1194-150)., orthopedic implant.
| Date | Aug 26, 2013 (initiated Jun 19, 2013) |
| Status | Terminated |
| Reason | Single packaging configuration used for the VERSA-FX-II Femoral Fixation System failed the leak test compromising the sterility of the product. |
| Root cause | Packaging process control |
| Action | The firm, Zimmer, sent an "URGENT MEDICAL DEVICE NOTIFICATION" letter dated July 11, 2013 to its customers. The letter describes the product, problem and actions to be taken. The customers were instructed to inspect the device according to the insert instructions; not use the device if damage to the corner of the inner tray is observed, and contact the firm for return and questions. Customers should also keep this notification in mind and inform Zimmer of product with this condition using zimmer.per@zimmer.com. If after reviewing this notification you have questions or concerns, please contac |
| Quantity | 85, 794 units in total |
| Distribution | Worldwide distribution: US Nationwide (including PR and USVI), and countries of: Israel, Argentina, Brazil, France, Mexico, Saudi Arabia, Beirut, China, Korea, San Salvador, Honduras, Canada, Australia, Switzerland, Germany, Arab Emirates, UK, Belgium, Egypt, Spain, France, Italy, Iran, Lebanon, Jor |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K830196 | CORSTREN COMPRESSION TUBE & PLATE Zimmer, Inc., Mar 25, 1983 |