medical Class II Updated 2018-05-30

Synthes (USA) Products LLC recalls Synthes Torque Limiting Handle, Part Number 03.231.013 Th

Recalled Product

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

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: 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
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