FDA recall Z-0359-2020

Product

TriMed Wrist Hook Dorsal Impactor, REF IMPCT-WHD; and TriMed Wrist Hook Volar Impactor, REF IMPCT-WHV, both nonsterile, Rx, The firm name on the labels is TriMed Inc., Santa Clarita, CA.

Reason for recall

The WHD/WHV impactors can rust over time due to an improper manufacturing process.

Distribution

Distribution was nationwide. There was military distribution but no government distribution. Foreign distribution was made to Australia, China, South Africa, and Sweden.

Key facts

Status

Ongoing

Initiation date

2018-09-28

Report date

2019-11-20

Voluntary/Mandated

Voluntary: Firm initiated

Location

Santa Clarita, CA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0359-2020