Recall Z-2428-2020 ยท HWC Screw, Fixation, Bone
PROVIDENCE MEDICAL TECHNOLOGIES
Ally Bone Screw - Product Usage:Bone Screws are indicated for use in bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation appropriate for the size of the device. Screws are intended for single use only. L Providence Medical Technology, Inc. 3875 Hopyard Road, Suite 300, Pleasanton, CA 94588, Rx Only.
| Date | Mar 29, 2019 |
| Status | Terminated |
| Reason | There may be dimensional manufacturing error that represents a potential safety risk to patients. |
| Root cause | Component design/selection |
| Action | On 03/29/2019, the firm sent an Customer Notification via email to Sales Representatives and Distributors who were in possession of the affected lots. The Customer Notification informed customers that the firm has determined that there may be non-conformances associated with bone screw and to not use any of the bone screws. Customer are instructed to: -immediately return the affected product, no later than 4/2/2019, and if they have any screws from different lots, these should also be returned. A return FedEx label is included with the email. Customers are also instructed that if the quant |
| Quantity | 208 units |
| Distribution | US Nationwide distribution including in the states of AZ, CA, FL, IL, IN, LA, MA, MO, NC, NJ, NY, OH, OR and TX. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K121713 | PMT BONE SCREWS Providence Medical Technology, Inc., Sep 27, 2012 |