FDA-Device2024-10-02Class II
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
TMJ Solutions Inc
Hazard
Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO
Sold states
US Nationwide distribution in the state of MN.
Affected count
1
Manufactured in
6059 King Dr, Ventura, CA, United States
Products
Stryker TMJ Unilateral Implant, REF: GHG010, consisting of the following components: Ref: CHG010AM, Anatomical Bone Model, Accessory, REF: CHG010RF, Glenoid Fossa Component, Right, REF: CHG010RM, Mandibular Component, Right.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3264-2024Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief