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
Recall
- Recall Number
- Z-1794-2021
- Event Number
- 87940
- Firm
- Wishbone Medical, Inc.
- FEI Number
- 3013680140
- Product Code
- HRS
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- April 30, 2021
- Terminated
- July 28, 2022
- Address
- 100 Capital Dr, Warsaw, IN, 46582-6704
Description
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
Nonconformities were discovered to the engineering specifications for implant plates and screws.
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 will send the exact replacement product to your facility. - If you have already disposed of product, please note this on the Acknowledgement and Response Form for credit to your account. - Complete and return the attached response form via email or post mail. We ask you to complete this form even if you do not have any of this product on hand. Please maintain this Field Safety Notice on file for your companys awareness.
Domestic: VA, PA, IN.
60 products