FDA recall Z-2786-2020

Product

Calcaneus Plate, Extensile, Medium, Right, Catalog Number CPF 202 - Product Usage: intended to be used for internal fixation of fractures and reconstruction of bones of the rearfoot, including the calcaneus.

Reason for recall

The contract manufacturer of the calcaneus plate inadvertently used the incorrect material to manufacture the plates (a titanium alloy rather than pure titanium).

Distribution

US Nationwide distribution including in the states of AZ, FL, and OH.

Key facts

Status

Terminated

Initiation date

2020-07-08

Report date

2020-08-19

Termination date

2020-10-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2786-2020