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US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 69 King Street, Dover, NJ, 07801
- Website
- —
- —
- —
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
- 3006721341
- DUNS Number
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Catalogue (124)
Page 2 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| LinkBio Instrument | 87-2001/03 | FDA UDI | Class I | Active |
| LinkBio Instrument | MCGAT | FDA UDI | Class I | Active |
| LinkBio Instrument | TLTCI01 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1903/24 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1903/00 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1901/10 | FDA UDI | Class I | Active |
| CORE Shoulder System | 87-9133/28R | FDA UDI | Class II | Active |
| LinkBio Instrument | 87-1908/12 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-6051/50 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1401 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1905/10 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1907/02 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1117/MR | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1901/03 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1901/12 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1117/LR | FDA UDI | Class I | Active |
| CORE Shoulder System | 87-9133/24L | FDA UDI | Class II | Active |
| CORE Shoulder System | 87-9134 | FDA UDI | Class II | Active |
| LinkBio Instrument | 87-1906/10 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1913/01 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1908/16 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1909/02 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-6051/56 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1903/10 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1903/31 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1909/01 | FDA UDI | Class I | Active |
| CORE Shoulder System | 87-9133/24R | FDA UDI | Class II | Active |
| CORE Shoulder System | 87-9136 | FDA UDI | Class II | Active |
| LinkBio Instrument | 87-1119/S | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1902/18 | FDA UDI | Class I | Active |
| CORE Shoulder System | 87-9133/20L | FDA UDI | Class II | Active |
| LinkBio Instrument | 87-1908/08 | FDA UDI | Class I | Active |
| LinkBio Instrument | MCLFT2 | FDA UDI | Class I | Active |
| CORE Shoulder System | 87-9139 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1901/00 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1902/14 | FDA UDI | Class I | Active |
| CORE Shoulder System | 87-9133/16R | FDA UDI | Class II | Active |
| LinkBio Instrument | 87-1910/01 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1906/14 | FDA UDI | Class I | Active |
| LinkBio Instrument | MCSLTP | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1903/02 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1901/04 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1909/11 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1905/16 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-2001/01 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1911/10 | FDA UDI | Class I | Active |
| LinkBio Instrument | TLUCI01 | FDA UDI | Class I | Active |
| CORE Shoulder System | 87-9133/16L | FDA UDI | Class II | Active |
| LinkBio Instrument | 87-1901/02 | FDA UDI | Class I | Active |
| LinkBio Instrument | 87-1119/M | FDA UDI | Class I | Active |
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FDA Recalls (51)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Mar 12, 2026 | Z-1810-2026 | — | open, classified | The CORE Workstation may display an incorrect "Planning Date " when viewing cases on the "Start Case" menu screen. |
| Jun 27, 2024 | Z-2445-2024 | — | open, classified | 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. |
| Apr 25, 2023 | Z-1674-2023 | — | open, classified | 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). |
| Mar 21, 2023 | Z-1531-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1526-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1527-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1550-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1548-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1537-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1513-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1538-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1551-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1512-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1545-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1547-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1507-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1553-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1535-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1536-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1524-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1520-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1518-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1516-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1552-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1517-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1530-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1549-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1510-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1554-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1508-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1521-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1534-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1529-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1546-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1541-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1539-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1543-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1523-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1528-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1532-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1519-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1533-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1515-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1525-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1509-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1514-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1542-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1544-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1522-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1540-2023 | — | open, classified | 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 |
| Mar 21, 2023 | Z-1511-2023 | — | open, classified | 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 |