Device Recall Synthes Torque Limiting Handle 의 리콜

Recall

80048

Class 2

Z-1916-2018

2018-05-04

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=164278

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.

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.