Recall Z-1794-2021 ยท HRS Plate, Fixation, Bone
Wishbone Medical, Inc.
WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number: PK-SMC0635NL-TI-US, PK-SMC0635NR-TI-US, PK-SMC0835NSL-TI-US, PK-SMC0835NSR-TI-US
| Date | Apr 30, 2021 |
| Status | Terminated |
| Reason | Nonconformities were discovered to the engineering specifications for implant plates and screws. |
| Root cause | Process control |
| Action | On April 30, 2021, Wishbone issued an Urgent Medical Device Removal notice to customers via letter notifying them WishBone Medical is voluntarily initiating a recall of the WishBone Medical Plates & Screws System products manufactured by a specified contract manufacturer. Immediate Actions to Take as the Customer/User: - Please examine your inventory for affected devices. - Please return product to WishBone Medical office. If returning to WishBone Medical office: WishBone Medical, Inc. 100 Capitol Drive Warsaw, IN 46582 - Once the product has been received by the WishBone Medical office, we |
| Quantity | 60 products |
| Distribution | Domestic: VA, PA, IN. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K180736 | WishBone Medical Plate and Screw System Wishbone Medical, Inc., Oct 4, 2018 |