Manufacturer
27 recalls in our database name Mako Surgical Corporation as the manufacturing or recalling firm.
Of the 27 recalls from Mako Surgical Corporation we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 2 (7%) 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.
Mako Surgical Corporation is recalling certain Stryker USB Converter components that may arrive non-functional or fail during use. Affected units are in Illinois and Arizona.
Stryker is recalling Mako MICS Handpieces due to a characterization issue that may cause unsuccessful checkpoint verification or bone cuts differing from the preoperative plan.
Mako Surgical Corporation is recalling 12 units of Mako Hip End Effectors due to a characterization issue that may cause discrepancies during bone preparation in certain Mako Total Hip procedures.
Mako Surgical Corporation is recalling 39 units of the 2.7 Degree Angled Sagittal Saw attachment because the bearings were ungreased.
Mako Surgical Corporation is recalling 2.7 Degree Straight Sagittal Saw attachments because the bearings were ungreased. The devices were distributed to facilities in 13 US states and three international countries.
Mako Surgical Corporation is recalling 910 units of the Makoplasty RIO Standard System and Ethernet to Fiber Optic Converter due to communication-connection errors.
Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Hip Procedure Tracking Kit because damaged reflective material may prevent camera detection.
Mako Surgical Corporation is recalling specific lots of the Stryker Mako Vizadisc Knee Procedure Tracking Kit because the reflective material may be damaged, preventing camera detection.
Mako Surgical Corporation is voluntarily recalling 10,606 Rio System Irrigation Clips because they are out of tolerance. The recall covers units distributed worldwide.
Mako Surgical Corporation is recalling 575 units of the Restoris MCK Onlay Insert Extractor because the hinge pin may disassociate.
Mako Surgical Corporation is recalling 126 Restoris MCK Tibial Baseplates due to incorrect sizing labels. The devices were distributed to facilities in the US and several international countries.
Mako Surgical Corporation is recalling the Makoplasty Partial Knee Application software because it may fail to display all necessary constants when the screen is full.
Mako Surgical Corporation is recalling the Total Hip Application software for the RIO system due to a display error that may hide essential constants.
Mako Surgical Corporation is recalling 20 MAKO RIO Standard System internal cPCI Card Cages due to an intermittent electrical problem that could cause a loss of system power.
Mako Surgical Corporation is recalling 777 MAKO RIO THA Application User Guides because five AFMEA Risk Control Measures are missing from the documents.
Mako Surgical Corporation is recalling 595 Stryker Restoris RIO Reamer Handles because they may fail to engage mating components during surgery.
Mako Surgical Corporation is recalling 10 units of the MAKOplasty Hip Array Kit Laminate 150230 because the product may list two part numbers for the RIO Base Array.
Mako Surgical Corporation is recalling 96 units of the RESTORIS PST RIO Offset Shell Impactor due to a potential disassociation of the orientation pin.
Mako Surgical Corporation is recalling 249 Robotic Arm Interactive Orthopedic System (RIO) units worldwide to revise the field manual.
Mako Surgical Corporation is recalling 146 units of the Restoris Multicompartmental Knee System because damaged packaging may have compromised the sterile barrier.
Mako Surgical Corporation is recalling RIO system locking pins and connectors because the pins are damaged during assembly.
Mako Surgical Corporation is recalling 228 units of the Restoris Partial Knee Application RIO because the surgical burr may continue spinning outside the intended boundary after controls are released.
Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Offset Shell Impactors because they may be damaged during surgery.
Mako Surgical Corporation is recalling 404 RESTORIS PST Acetabular Straight Shell Impactors due to the potential for intraoperative damage.
Mako Surgical Corporation is recalling 404 RESTORIS PST Straight Shell Impactors because they may be damaged during surgery.
Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.
MAKO Surgical Corp.
medical device company
Source: Wikidata (Q17107854), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.