Wishbone Medical Inc.
United Statesfrom the FDA registration address FDA establishment FEI 3013680140
Wishbone Medical Inc. is a medical device manufacturer, with 3,014 devices listed and 3 FDA recalls as of 12 Nov 2026.
- Devices
- 3,014
- Registrations
- FDA
- FDA recalls
- 32 ongoing
Registry facts
- Registries
- FDA GUDID 3,000
- Device classes
- FDA Class II 2,735
- FDA Class I 265
- FDA recalls
- Identifiers
- FDA FEI 3013680140
What Wishbone Medical Inc. makes
WishBone Medical Inc. manufactures orthopaedic fixation hardware, including non-bioabsorbable titanium plates, screws, and bone washers for fracture stabilization and spinal applications. Their portfolio also includes single-use surgical tools such as drill guides, positioning instruments for prosthesis implantation, and procedure kits designed for orthopaedic surgeries. Examples include locking and cortical screws, compression plates, and modular systems like the PRIMA Femoral Locking Plate System.
The company’s devices are classified under FDA’s Class I and Class II categories and are listed in the FDA’s Unique Device Identification (UDI) database. Their products are intended for use in orthopaedic procedures and are regulated under U.S. medical device laws, adhering to applicable standards for safety and performance. The manufacturer operates from the United States.
Catalogue
Search and filter all 3,014 devicesShowing 1-50 of 3,014
Company details
- FDA FEI number
- 3013680140
- Address
- 1560 N State Road 5, Larwill, IN, 46764
FDA recalls
FDA recall records list 3 recalls initiated by WISHBONE MEDICAL INC., the earliest on 2021-04-30 and the most recent on 2024-04-05. By recorded status: 2 ongoing and 1 terminated. The reasons filed fall into these groups: packaging and manufacturing or quality process. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 1
- 2022 0
- 2023 1
- 2024 1
- 2025 0
- 2026 0
2024
- 5 Apr 2024 Z-1808-2024 Class II Ongoing 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.
2023
- 4 Jan 2023 Z-1102-2023 Class II Ongoing 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.
2021
- 30 Apr 2021 Z-1794-2021 Class II Terminated Nonconformities were discovered to the engineering specifications for implant plates and screws.
Frequently asked questions
How many devices does WISHBONE MEDICAL INC. have in the registry?
The registry currently lists 3014 devices for WISHBONE MEDICAL INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list WISHBONE MEDICAL INC.'s devices?
Among its 50 most recently registered devices, WISHBONE MEDICAL INC. has devices listed in FDA GUDID (50 devices).
What risk classes do WISHBONE MEDICAL INC.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for WISHBONE MEDICAL INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for WISHBONE MEDICAL INC.?
FDA recall records list 3 recalls initiated by WISHBONE MEDICAL INC., the most recent initiated on 5 Apr 2024. 2 of them are recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from WISHBONE MEDICAL INC. in the registry?
The most recently registered devices listed for WISHBONE MEDICAL INC. include Smart Correction 10-700-24006PA-0, Smart Correction 11-705-430151S, WishFIX PK-EFC0212SS-08-US and Procedure Kit Straight Compression Plate 4 hole with 3.5mm Instruments Ti PK-SCP3504-TI.