Synthes (USA) Products LLC: Medical Device Recall in 2018 - (Recall #: Z-1916-2018)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2018.

Data Source: FDA.

Product Description:

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

Product Classification:

Class II

Date Initiated: May 4, 2018

Date Posted: May 30, 2018

Recall Number: Z-1916-2018

Event ID: 80048

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.

Status: Terminated

Product Quantity: 50

Code Information:

H344006-02, H344006-03, H344006-04, H344006-05, H344006-06, H344006-07, H344006-08, H344006-09, H344006-10, H344006-11, H344006-12, H344006-13, H344006-14, H344006-15, H344006-16, H344006-17, H344006-18, H344006-19, H344006-20, H344006-21, H344006-22, H344006-23, H344006-24, H344006-25, H344006-26, H344006-27, H344006-28, H344006-29, H344006-30, H344006-31, H344006-32, H344006-33, H344006-34, H344006-35, H344006-36, H344006-37, H344006-38, H344006-39, H344006-40, H344006-41, H344006-43, H344006-45, H344006-46, H344006-47, H344006-48, H344006-49, H369323-03, H369323-04

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated