Reported May 30, 2018 · Terminated
Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
Synthes (USA) Products LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Synthes (USA) Products LLC · 1301 Goshen Pkwy · West Chester, PA · 19380-5986
Is this the product you have?
- Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
- Lot codes and dates
H344006-02H344006-03H344006-04H344006-05H344006-06H344006-07H344006-08H344006-09H344006-10H344006-11H344006-12H344006-13H344006-14H344006-15H344006-16H344006-17H344006-18H344006-19H344006-20H344006-21H344006-22H344006-23H344006-24H344006-25H344006-26H344006-27H344006-28H344006-29H344006-30H344006-31H344006-32H344006-33H344006-34H344006-35H344006-36H344006-37H344006-38H344006-39H344006-40H344006-41H344006-43H344006-45H344006-46H344006-47H344006-48H344006-49H369323-03H369323-04
- Amount recalled
- 50
Where it was sold
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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