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BEE HA Cage
NGMedical GmbH · Model Cervical 9x16 mm 12° · UDI-DI 04251631404064
ODP
Prescription
1
510(k) clearances
1,116
Adverse events (3 deaths)
11
Recalls
347
Facilities
Description
BEE HA 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 implants formed conically from anterior to posterior. In the lateral view, the implant has a slightly lordotic form. The cage disposes of 4 pins on both bone facing surfaces. BEE HA implants are made of PEEK-OPTIMA HA ENHANCED and pins made out of titanium alloy (Ti6Al4V) according to ASTM F136. It is not allowed to use BEE HA implants in contact with components of other manufacturers.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2025-11-03 | Orthofix U.S. LLC | Labeling contains claims that are not consistently present. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2023-07-12 | Medicrea International | There is a potential for a product packaging non-conformity issue which presents as a pinhole in either the inner or outer pouch. |
| 2020-09-30 | XTANT Medical | Cervical Implants contain a label that incorrectly identifies the grade of titanium used. |
| 2013-10-07 | RTI 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 |
| 2013-02-05 | SpineNet | The 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 |
| 2012-06-15 | Exactech, 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 |
| 2011-09-23 | Synthes 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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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.