Z-1794-2021Class II

WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number...

Name: Z-1794-2021 WishBone Medical Plate and Screw System - Screw, Fixation, Bone, Washer, Bolt Nut. Part Number...
Creator: Wishbone Medical, Inc.
Published: 2021-04-30
License: https://open.fda.gov/license/

Wishbone Medical, Inc. / initiated 2021-04-30 / Terminated / root cause: manufacturing process

FDA source

Wishbone Medical, Inc. began a recall of 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... on 2021-04-30. FDA classified it as Class II and gives the reason as "Nonconformities were discovered to the engineering specifications for implant plates and screws". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1794-2021
Classification: Class II
Status: Terminated
Initiated: 2021-04-30
Posted: 2021-06-04
Terminated: 2022-07-28
Recalling firm: Wishbone Medical, Inc.
Product: 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
Product code: HRS Plate, Fixation, Bone
Reason for recall: Nonconformities were discovered to the engineering specifications for implant plates and screws.
Root cause tag: manufacturing process
FDA 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 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 commerce: 60 products
Distribution: Domestic: VA, PA, IN.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1794-2021
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1794-2021	Class II	Terminated	Voluntary: Firm initiated	2021-06-16	2021-06-04

Product code HRS

K180736Class IIWishBone Medical Plate and Screw SystemWishbone Medical, Inc. / cleared 2018-10-04

Process control is the most common named cause of a device recall11 SEP 2026 / by Medical Device Manufacturing

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)