LinkBio Corp.
United StatesFDA applicant, unverified FDA FEI 3006721341
LinkBio Corp. is a medical device manufacturer, with 127 devices listed in FDA GUDID and FDA 510(k) (FDA Class I and II) and 51 FDA recalls as of 13 Nov 2026.
- Devices
- 127
- Registrations
- FDA
- FDA recalls
- 5151 ongoing
Registry facts
- Registries
- FDA GUDID 125
- FDA 510(k) 2
- Device classes
- FDA Class I 112
- FDA Class II 15
- FDA recalls
- Identifiers
- FDA FEI 3006721341
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 127 devicesShowing 1-50 of 127
Company details
- FDA FEI number
- 3006721341
- Address
- 69 King Street, Dover, NJ, 07801
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 49
- 2024 1
- 2025 0
- 2026 1
2026
- 12 Mar 2026 Z-1810-2026 Class II Ongoing The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen.
2024
- 27 Jun 2024 Z-2445-2024 Class II Ongoing The LinkSymphoKnee Patella Sizing Template was incorrectly labeled. The markings on two arms of the instrument were mixed up because the triangular Patella Sizing Template was inserted upside down into the laser marking process.
2023
- 25 Apr 2023 Z-1674-2023 Class II Ongoing Contains the incorrect implant in the packaging. The packaging incorrectly contains the opposite side of the implant (Lateral-Right/Medial-Left instead of Medial-Right/Lateral-Left).
- 21 Mar 2023 Z-1507-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1508-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1509-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1510-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1511-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1512-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1513-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
Full distribution text
Show the 25 most recent of 51 recalls
2023
- 21 Mar 2023 Z-1514-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1515-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1516-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
Full distribution text
- 21 Mar 2023 Z-1517-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1518-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1519-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1520-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
Full distribution text
- 21 Mar 2023 Z-1521-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1522-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1523-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1524-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1525-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1526-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
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- 21 Mar 2023 Z-1527-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
Full distribution text
- 21 Mar 2023 Z-1528-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
Full distribution text
- 21 Mar 2023 Z-1514-2023 Class II Ongoing Additional Label Warnings: Amendment / reinforcement of the Surgical Technique and future product training on the updated technique, due to early aseptic loosening or increased wear of the implant caused by suboptimal positioning of the implant or inadequate cementing technique leading to an unsatisfactory surgical result, and in the worst case, intervention or revision earlier than expected
Frequently asked questions
How many devices does LinkBio Corp. have in the registry?
The registry currently lists 127 devices for LinkBio Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list LinkBio Corp.'s devices?
Among its 50 most recently registered devices, LinkBio Corp. has devices listed in FDA GUDID (50 devices).
What risk classes do LinkBio Corp.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for LinkBio Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for LinkBio Corp.?
FDA recall records list 51 recalls initiated by LinkBio Corp., the most recent initiated on 12 Mar 2026. 51 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 LinkBio Corp. in the registry?
The most recently registered devices listed for LinkBio Corp. include LinkBio Instrument 87-2003/01, LinkBio Instrument 87-2003/02, LinkBio Instrument 87-2003/03 and LinkBio Instrument 87-1903/21.