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
FDA Recall Z-1794-2021 · Posted None
Advertisement
Recalling FirmWishbone Medical, Inc.
Recall StatusTerminated
Product CodeHRS
Date Initiated2021-04-30
Date Terminated2022-07-28
Product Quantity60 products
Reason for Recall
Nonconformities were discovered to the engineering specifications for implant plates and screws.
Firm 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 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.
Root Cause
Process control
Distribution Pattern
Domestic: VA, PA, IN.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement