Warsaw, IN, United States
Wishbone Medical, Inc. recalls
3 recalls recorded since 2018, most recently on 5 April 2024. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)2
Terminated or completed1
Class I (FDA)0
Ongoing Class II Medical devices
- Recall started
- 5 April 2024
- Reason
- The products in this lot are incorrectly packed with a Stainless-Steel implant instead of a Titanium implant as the packaging and part number indicated.
- Distribution
- US distribution to Florida, New Jersey and Connecticut.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1808-2024
- WishFIX Growth Control Plating System, Model Number: TEFCS28-080US. Orthopedic device.
Ongoing Class II Medical devices
- Recall started
- 4 January 2023
- Reason
- Firm identified that user may be unable to adjust the length of the Smart Correction Dual Joint Express Struts due to the collar release pin backing out. This may lead to a delay in correction.
- Distribution
- US Nationwide distribution in the state of South Carolina.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1102-2023
- WishBone Medical Smart Correction Dual Joint Express Struts, external skeleton fixation device Type Part Number XXS 10-702-080095-0 XS 10-702-095115-0 Short 10-702-115150-0 Me
Terminated Class II Medical devices
- Recall started
- 30 April 2021
- Terminated
- 28 July 2022
- Reason
- Nonconformities were discovered to the engineering specifications for implant plates and screws.
- Distribution
- Domestic: VA, PA, IN.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1794-2021
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.