FDA recall Z-0884-2020

Product

Brasseler USA KM169-39-76 Steinmann Pin Single Diamond Smooth, Diameter 2.8 mm, Length 228 mm Product Usage: A Steinmann Pin is used for internal fixation of large bone fractures.

Reason for recall

103 packaged and labeled tubes (103 product tubes with 6 pins per tube) of KM168-39-76 Single Diamond Smooth Steinmann Pins were labeled with the incorrect product labels. The tubes were incorrectly labeled as KM169-39-76 Single Diamond Threaded Steinmann Pins.

Distribution

US: AZ, AR, FL

Key facts

Status

Terminated

Initiation date

2019-12-11

Report date

2020-02-05

Termination date

2021-02-12

Voluntary/Mandated

Voluntary: Firm initiated

Location

Savannah, GA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0884-2020