FDA recall Z-2219-2024

Product

Stryker Hoffman LRF Wire Tensioner REF 4933-9-100, a component of the Hoffmann LRF System.

Reason for recall

The adjustment ring on the device may become loose resulting in the wire tension not being able to be set correctly.

Distribution

Worldwide - US Nationwide distribution in the states of AZ, CA, CO, FL, GA, KY, MA, MI, NE, NJ, OH, OR, and TX. The countries of Germany, Japan, Netherlands, and United Kingdom.

Key facts

Status

Ongoing

Initiation date

2024-05-09

Report date

2024-07-03

Voluntary/Mandated

Voluntary: Firm initiated

Location

Selzach, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2219-2024