Recall Z-1694-2015 ยท NDJ Screw, Fixation, Bone, Non-Spinal, Metallic
Zimmer, Inc.
Cortical Screw for M/DN Intramedullary Fixation. Metaphyseal/Diaphyseal Nail System, Orthopedic surgical device.
| Date | May 29, 2015 (initiated Apr 29, 2015) |
| Status | Terminated |
| Reason | The entire scope of 4.5mm Cortical Screws listed as compatible with the M/DN system is not compatible with the M/DN system. This has the potential to lead to a situation in which the screw would bind upon entering the nail and have to be removed during the surgery or removal of the screw after fracture healing. |
| Root cause | Component design/selection |
| Action | Zimmer sent an Urgent Medical Device Recall letter dated April, 29, 2015, to all affected customers.On 4/29/2015. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers were instructed to review the notification and ensure affected personnel are aware of the contents. Locate all affected product and quarantine them immediately. Return the recalled product along with completed Inventory Return Certification Form. Notify Zimmer of any further distri |
| Quantity | 289,616 |
| Distribution | Worldwide Distribution - US (nationwide) and Internationally to Canada, Brazil, Mexico, Bahamas, Nicaragua, Singapore, China, Japan, Malaysia, Taiwan, Thailand, Korea, Spain, Belgium, Switzerland, India, Germany, England, Italy, Saudi Arabia, Lebanon, Libya, United Arab Emirates, Algeria, France, Un |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.