FDA recall Z-3264-2024

Product

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.

Reason for recall

Patient-fitted temporomandibular (TMJ) prothesis contained incorrect components, SterileEO

Distribution

US Nationwide distribution in the state of MN.

Key facts

Status

Ongoing

Initiation date

2024-07-24

Report date

2024-10-02

Voluntary/Mandated

Voluntary: Firm initiated

Location

Ventura, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-3264-2024