Device Recall ReClaim Reamer Extension 의 리콜

Recall

64285

Class 2

Z-0972-2013

2013-02-25

2013-03-20

Terminated

United States

2013-12-30

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115761

The tabs on the reamer extension device have broken. depuy is notifying surgeons of the issue to increase the awareness and to ask surgeons and users to look for tabs before and after surgery to reduce any potential that the tabs are left in the patient. once the root cause is determined and a design change is implemented, depuy will conduct a formal swap-out of the affected devices.

DePuy Synthes sent a Urgent Information Medical Device Correction Notice to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Customers were instructed upon visual inspection, if the reamer extension is found to have one or more tabs broken, please do not use the reamer extension. The reamer extension will still engage with one tab intact and no clinical implications have been identified with the use of the reamer extension with one tab, but DePuy recommends it be returned and the alternate reamer extension device be used. If both tabs are broken, the reamer extension will not engage and DePuy recommends it be returned and the alternate reamer extension device be used. A reamer extractor is available in the instrument kit for removal of the reamer if necessary. In order to reduce the risk of breaking the tabs during surgery, the Reamer Extension should only be used to drive the Distal Reamer axially within the patients femoral canal. The instrument is NOT intended to be used for side-cutting or lateralizing the femoral canal, therefore, no off-axis force should be applied during distal reaming. The purpose of this communication is to inform you of this device correction and request acknowledgement of receipt of this letter by signing and returning the Surgeon Response Card within 14 days of receiving this notice. Response cards should be faxed to Fax Number: 574-371-4939. For product-related questions, please contact your local DePuy Orthopaedics Sales Representative. For clinical-related questions from surgeons, please have them contact DePuys Scientific Information Office at 1-888-554-2482 (M-F; 8 am to 5 pm EST.) For questions about device correction information provided, 574-372-7333 (M-F: 8 am to 5 pm EST.)