FDA recall Z-0100-2023

Product

SPEED 9X10X10mm Continuous Compression Implant, Product No. SE-0910

Reason for recall

The subject products are being recalled because they contain the incorrect size drill guide and will not prepare the bone correctly for the size of the implant included in the sterile kit. If the incorrect drill guide is used, there is potential for bone damage due to incorrectly placed drill holes for the implant included in the kit.

Distribution

US Nationwide distribution.

Key facts

Status

Ongoing

Initiation date

2022-09-27

Report date

2022-10-26

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0100-2023