FDA recall Z-2393-2018

Product

Tibial Nail, Standard T2 Tibia ¿12x315 mm, Product Number 18221231S

Reason for recall

The manufacturer has discovered that potentially out-of-specification products may have left the factory. Non-conforming cannulation of the nails may result in reduced component strength and potentially premature nail breakage.

Distribution

The products were distributed to the following US states: AL, Co, FL, KY, NC, TN, UT, and WA.

Key facts

Status

Terminated

Initiation date

2018-04-27

Report date

2018-07-18

Termination date

2020-05-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

Selzach, Switzerland

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2393-2018