FDA recall Z-0453-2022

Product

DYNANAIL MINI, Endcap +6mm, REF 2600-05-006, Rx Only, Sterile

Reason for recall

The firm identified a nonconformance in Lot 04882 involving the endcap being manufactured to a longer length than indicated in product specifications, introducing the risk of the +6 mm endcap not seating flush with the nail while inserting during a procedure.

Distribution

Domestic: CA, FL, GA, IL, IN, MA, MD, TX, and WA.

Key facts

Status

Ongoing

Initiation date

2021-11-17

Report date

2022-01-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Atlanta, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0453-2022