Z-1916-2018 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 30, 2018
- Initiation Date
- May 4, 2018
- Termination Date
- October 21, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 50
Product Description
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 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.
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