FDA Device Intelligence
Home › METICULY COMPANY LIMITED › METICULY Patient-specific titanium mesh implant

METICULY Patient-specific titanium mesh implant

METICULY COMPANY LIMITED · Model CP-300 · UDI-DI 08859751216008

GXN Prescription
10
510(k) clearances
828
Adverse events (2 deaths)
11
Recalls
49
Facilities

Description

METICULY Patient-specific titanium mesh implant (advanced design) non-sterile

Recalls

DateFirmReason
2018-08-22Zimmer Biomet, Inc.Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22Zimmer Biomet, Inc.Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22Zimmer Biomet, Inc.Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22Zimmer Biomet, Inc.Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22Zimmer Biomet, Inc.Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2018-08-22Zimmer Biomet, Inc.Spin Down RapidFlap nut that interfaces with the outer plate was assembled incorrectly.
2017-06-10Kelyniam 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
2017-06-10Kelyniam 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
2017-06-10Kelyniam 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
2017-06-10Kelyniam 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

Query this across every FDA database — by API.

Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

Get your free API keyRead the docs
Data 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.