Recall Z-1808-2024 ยท OBT Plate, Bone, Growth Control, Pediatric, Epiphysiodesis
Wishbone Medical, Inc.
WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
| Date | May 10, 2024 (initiated Apr 5, 2024) |
| Status | Open, Classified |
| Reason | The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated. |
| Root cause | Nonconforming Material/Component |
| Action | On April 5, 2024 an email with an attached MEDICAL DEVICE RECALL NOTICE was sent to all Sales Representatives, Distributors, Institutions, and Physicians who have received a product from the affected lot. Immediate Actions to Take as the Customer/User: 1. Complete and return the attached response form via email (see below) or post mail to the address below. Please complete this form even if you do not have any of this product on hand. 2. Please examine your inventory for affected devices. 3. Please return any affected product either to your distributor or to WishBone Medical at: WishBone Medic |
| Quantity | 60 units |
| Distribution | US distribution to Florida, New Jersey and Connecticut. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K182704 | WishBone Guided Growth System Wishbone Medical, Jun 25, 2019 |