Z-1916-2018Class II

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

Name: Z-1916-2018 Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture...
Creator: Synthes (USA) Products LLC
Published: 2018-05-04
License: https://open.fda.gov/license/

Synthes (USA) Products LLC / initiated 2018-05-04 / Terminated / root cause: design

FDA source

Synthes (USA) Products LLC began a recall of Synthes Torque Limiting Handle, Part Number 03.231.013 This device is used in systems indicated for fracture fixation on 2018-05-04. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-1916-2018
Classification: Class II
Status: Terminated
Initiated: 2018-05-04
Posted: 2018-05-23
Terminated: 2019-10-21
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.
Product code: HXX Screwdriver
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.
Root cause tag: design
FDA 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: [email protected] 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 in commerce: 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.
Product codes and lots: 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

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1916-2018
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1916-2018	Class II	Terminated	Voluntary: Firm initiated	2018-05-30	2018-05-23

Product code HXX

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)