Manufacturer
4 recalls in our database name Kelyniam Global, Inc. as the manufacturing or recalling firm.
Of the 4 recalls from Kelyniam Global, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.
The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.
Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.
Kelyniam Global is recalling 23 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.
Kelyniam Global is recalling 54 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for clearance.
Kelyniam Global is recalling two Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.
Kelyniam Global is recalling 16 Custom Skull Implants because significant design changes were not validated or submitted to the FDA for marketing clearance.