Synthes (USA) Products LLC: Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation.

Recall number

Z-1916-2018

Recalling firm

Synthes (USA) Products LLC

Product

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

Status

Terminated

Initiated

2018-05-04

Posted

not on file

Terminated

2019-10-21

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.

Root cause

Component design/selection

Action

An Urgent Medical Device Recall Notification letters dated May 4, 2018, were distributed to customers. The letter requests that customers take the following actions: Potential Patient Impact: The subject, Torque Limiting Handle, may demonstrate a degradation of function with the adapter collar sticking, and/or not retaining the mating adapter male shaft of the driver component. In addition, the ball bearings may corrode over time causing a failure in the torque limiting feature. The following potential scenarios could occur: " Malunion/nonunion and device loosening if there is a degradation of function and too much or too little torque is applied. " Adverse tissue reaction if there is corrosion and any debris enters an open incision. " Surgical delay due to the time required to investigate and decide next steps if the instrument fails during surgery. If you have no product to be returned: " Return the Verification Section (page 3 of this letter) to DePuy Synthes by: o Fax: 866-853-1969 or o Scan/email: Synthes7370@stericycle.com NOTE: If the Verification Section is completed on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual in page number three (3) of this notification. 3. Forward this notice to anyone in your facility that needs to be informed. 4. If any of the subject product has been forwarded to another facility, contact that facility to arrange return. 5. Keep a copy of this notice visibly posted for awareness until all product subject to this recall (removal) have been returned. While processing your returns, please maintain a copy of this notice with the product subject to this recall (removal) and keep a copy for your records. For further questions, please call (610) 719-5450.

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.

Lot, serial or model codes

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

510(k) numbers

not on file

PMA numbers

not on file

Product code

HXX

Firm FEI

3008812560

Firm city

West Chester

Firm state

PA

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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