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U.S. Department of Health and Human Services

Class 2 Device Recall WishBone Medical Plate and Screw System

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 Class 2 Device Recall WishBone Medical Plate and Screw Systemsee related information
Date Initiated by FirmApril 30, 2021
Create DateJune 04, 2021
Recall Status1 Terminated 3 on July 28, 2022
Recall NumberZ-1794-2021
Recall Event ID 87940
510(K)NumberK180736 
Product Classification Plate, fixation, bone - Product Code HRS
ProductWishBone 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
Code Information Lot Number: 20837, 124555, 124557, 124558, 124557, 124556, 124555, 124554, 124553, 124552, 124551, 124550, 124548, 124547, 124546, 124545, 124636, 124634, 124632, 124631, 124630, 22571, 20846, 20845, 20844, 20842, 24092, 22461, 24287, 24091, 24282, 22462, 22463, 24090, 24289, 20837, 22464, 24284, 22465, 22014, 24285, 22554, 22466, 22196, 24292, 22529, 24085, 22195, 22469, 24291, 22553, 24083, 24087, 22470, 24283, 22560, 24082, 24088, 124630, 134631, 124632, 134633, 124634, 124636, 124545, 124546, 124547, 124548, 124550, 125678, 124551, 126058, 124552, 125677, 124553, 125675, 124554, 124555, 125451, 124556, 125452, 124557, 125453, 124558, 125454 
FEI Number 3013680140
Recalling Firm/
Manufacturer		 Wishbone Medical, Inc.
100 Capital Dr
Warsaw IN 46582-6704
For Additional Information ContactMary Wentorf
574-306-4006 Ext. 405
Manufacturer Reason
for Recall		Nonconformities were discovered to the engineering specifications for implant plates and screws.
FDA Determined
Cause 2		Process control
ActionOn 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.
Quantity in Commerce60 products
DistributionDomestic: VA, PA, IN.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = HRS
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