Synthes Material Mix 의 리콜

Recall

66551

Class 2

Z-0393-2014

2013-10-15

2013-11-26

Terminated

United States

2015-08-31

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=122581

One material batch used for production of the affected parts of the synthes material mix were mixed in with an incorrect material with a lower than specified hardness and corrosion resistance.

SYNTHES sent an Urgent Notice: Medical Device Recall letter dated October 15, 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 at the end of the letter by checking the appropriate box indicating affected product was located. Customers were also asked to indicate the number of devices found and note the Return Authorization Number. Return the Verification Form with the product to: Credit/Returns Synthes 1101 Synthes Avenue Monument, CO 80132 Customers should also return the Verification Form if no affected product was found in their inventory. Return all documents to Synthes by fax: 888-679-4875 or Scan/email: FieldAction@synthes.com Customers with questions were instructed to call 610-719-5450 or contact their Synthes Sales Consultant. For questions regarding this recall call 610-719-5000.