Device Recall Synthes Titanium Cannulated Humeral Nail 의 리콜

Recall

66419

Class 2

Z-0407-2014

2013-07-30

2013-11-27

Terminated

United States

2015-09-10

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122363

The packaging incorrectly depicts the synthes titanium cannulated humeral nail as a 3 distal hole nail instead of a 2 distal locking hole nail.

Synthes sent an Urgent Notice: Medical Device Recall letter dated July 30, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to call Synthes at 1-800-479-6329 to obtain a Return Authorization Number, complete the Verification Section and return to Credit/Returns, Synthes, 1101 Synthes Avenue, Monument, CO 80132. If customers do not have any affected product they should still complete Verification Form and return to Synthes by fax to 1-888-731-7954 or Scan/email: FieldAction@synthes.com. Customers with questions were instructed to call 610-719-5450. For questions regarding this recall call 610-519-5000.