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BEE Cervical Cage

NGMedical GmbH · Model BEE Cage cervical 10 x 14 mm 8° S · UDI-DI 04251631414902

ODP Prescription
1
510(k) clearances
1,116
Adverse events (3 deaths)
11
Recalls
345
Facilities

Description

BEE® Cages were especially adapted to the local anatomy to secure the surgical outcome at the best. The caudal side is flat, the cranial side is domed and the implant is formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic formand is available in 4°, 8° and 12° lordosis. The cage disposes of 4 pins on both bone facing surfaces. BEE® implants are made of titanium alloy (Ti6Al4V_ELI) according to ASTM-F 3001. It is not allowed to use BEE® implants in contact with components of other manufacturers.

Recalls

DateFirmReason
2025-11-03Orthofix U.S. LLCLabeling contains claims that are not consistently present.
2025-11-03Orthofix U.S. LLCLabeling contains claims that are not consistently present.
2023-07-12Medicrea InternationalThere is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12Medicrea InternationalThere is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2023-07-12Medicrea InternationalThere is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch.
2020-09-30XTANT MedicalCervical Implants contain a label that incorrectly identifies the grade of titanium used.
2013-10-07RTI Surgical, Inc.As the result of a recent internal review of regulatory documents, we have determined that the 10 mm x 12 mm Webless C-Plus implants were incorrectly documented as meeting the requ
2013-02-05SpineNetThe recall decision has been made because because it has recently been determined that the instructions for use (IFU) had certain statements that should have been removed prior to
2012-06-15Exactech, Inc.Exactech, Inc. initiated a recall of Equinoxe Replicator Plates, Equinoxe Locking Screws, Equinoxe Compression Screw Kits, Equinoxe Fracture Adapter Tray Screws, and Octane-C Inter
2011-09-23Synthes USA (HQ), Inc.LABELING CORRECTION - Following review of labeling and promotional materials associated with the Zero-P Implant system, it was found that the materials reference a study where PEEK

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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.