Recall Z-1916-2018— Synthes (USA) Products LLC
Class II · Terminated
Class II FDA medical device recall by Synthes (USA) Products LLC, initiated 2018-05-04, terminated 2019-10-21. FDA's recall record names no specific 510(k) clearance for this event. Product: Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.. Reason: 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..
- Recalling firm
- Synthes (USA) Products LLC
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2018-05-04
- Terminated
- 2019-10-21
- Firm location
- West Chester, PA, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.