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Meticuly
METICULY COMPANY LIMITED · Model CP-323 · UDI-DI 08859751216237
GXN
Prescription
10
510(k) clearances
827
Adverse events (2 deaths)
11
Recalls
49
Facilities
Description
Meticuly’s patient-specific titanium mesh implant is a device designed individually to replace each patient’s bony voids in the cranial and/or craniofacial skeleton. The craniofacial skeleton comprises of frontal bone, temporal bone, occipital bone, parietal bone, sphenoid bone, supraorbital process, vomer. This patient-specific device is intended to be used with titanium screws. The implant is made of titanium alloys produced via additive manufacturing (Laser Powder Bed Fusion). The surgeon approves the design of the mesh implant prior to fabrication of the implant device.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2018-08-22 | Zimmer Biomet, Inc. | Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly. |
| 2017-06-10 | Kelyniam Global, Inc. | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the |
| 2017-06-10 | Kelyniam Global, Inc. | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the |
| 2017-06-10 | Kelyniam Global, Inc. | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the |
| 2017-06-10 | Kelyniam Global, Inc. | Significant design changes made to the Custom Skull Implant (CSI) devices, such as removing pressure relief holes across the length of the device and adding suture holes along the |
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Get your free API keyRead the docsData compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.