Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
Reported: May 30, 2018 Initiated: May 4, 2018 #Z-1916-2018
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.
Details
- Recalling Firm
- Synthes (USA) Products LLC
- Units Affected
- 50
- Distribution
- 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.
- Location
- West Chester, PA
Frequently Asked Questions
What product was recalled? ▼
Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.. Recalled by Synthes (USA) Products LLC. Units affected: 50.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on May 30, 2018. Severity: Moderate. Recall number: Z-1916-2018.
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