Device Recall Charnley Pin Retractor and Handle Set 의 리콜

Recall

69052

Class 2

Z-0061-2015

2014-08-27

2014-10-09

Terminated

United States

2015-11-17

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=129458

The small extraction peg of the charnley pin retractor and handle set is breaking from the pin.

The firm, Depuy Synthes, sent an "URGENT INFORMATION - RECALL NOTICE" dated August 27, 2014 to their consignees. The recall notification included a description of the reason for recall, affected product, clinical implications, and instructions for responding to the formal recall notification. The customers were instructed to cease using the affected components immediately, quarantine all affected components in a manner that ensures the affected components are not used; return affected devices immediately to your DePuy; if any affected product has been forwarded to another facility, contact that facility immediately to communicate recall and arrange return; maintain awareness and copy of this notice, and complete and return the Reconciliation forms via fax to 574-371-4939 or emailed to kearle@its.jnj.com. For questions about the device recall information provided, please contact Recall Coordinator, at 574-371-4917 (M-F; 8 a.m. - 5 p.m. EDT) or email Kearle@its.jnj.com. For product-related questions, please contact your local DePuy Orthopaedics, Inc. Sales Consultant. For clinical questions from hospitals/user facilities, please contact DePuy Orthopaedics, Inc. Scientific Information Office at 1-888-554-2482 (M-F; 8 a.m. - 5 p.m. EDT).