Synthes Torque Limiting Handle recall: Impurity Out of Spec
Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
Why was Synthes Torque Limiting Handle 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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
- Product
- Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.
- Recalling firm
- Synthes (USA) Products LLC
- Quantity
- 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.
- Recall date
- May 30, 2018
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)