FDA recall Z-2287-2023

Product

ProPlan CMF Patient-Specific Guide, Mandible guides (3A & 3B)-Intended to guide the marking of bone and/or guide surgical instruments in mandibular and maxillofacial surgical procedures. Identification number: SD900.101

Reason for recall

Wrong versions of guides 3A and 3B (Patient Specific) were shipped prior to the re-design request

Distribution

US Nationwide distribution in the state of KY.

Key facts

Status

Completed

Initiation date

2023-06-19

Report date

2023-08-09

Voluntary/Mandated

Voluntary: Firm initiated

Location

Heverlee, N/A, Belgium

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2287-2023