FDA recall Z-1916-2018

Product

Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.

Reason for recall

The adapter may demonstrate a degradation of function as the final products were assembled with ball bearings of high carbon content that is likely to rust prematurely.

Distribution

USA (nationwide) Distribution to the states of : AK, CA, FL, ID, IN, KS, KY, LA, MD, MI, MT, NC, NJ, NY, OH, OK, PA, SD, TN, TX, UT, WI, and WV.

Key facts

Status

Terminated

Initiation date

2018-05-04

Report date

2018-05-30

Termination date

2019-10-21

Voluntary/Mandated

Voluntary: Firm initiated

Location

West Chester, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1916-2018