Synthes Spine TPAL Spacer System. 의 리콜

Recall

60003

Class 2

Z-0161-2012

2011-09-23

2011-11-04

Terminated

United States

2014-12-18

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=104221

Labeling correction for medical device - previous labeling and promotional materials associated with the t-pal spacer system reference the use of t-pal spacer with allograft material. t-pal spacer is currently indicated for use with autograft material. all accounts with record of receiving t-pal implant will receive notification of the labeling correction and a copy of the updated brochure. all.

SYNTHES sent an URGENT MEDICAL DEVICE LABELING CORRECTION letter dated September 23, 2011, to all affected customers. The labeling has been revised. Updated information packets have been sent to all accounts which included the final labeling and communications to accounts and sales force. Customers were instructed to review the updated supplemental labeling provided in the package Customers were instructed to attach the supplementary technique page to an T-PAL Spacer Brochure that may be in their facility. They can access an electronic version of the Brochure by accesssng Product Literature at the following link: http://us.synthes.com. The new version can be identified by code J10120 located at the bottom right corner of the back cover. To confirm receipt and understanding of the information, customers were requested to complete the Verification Section of the letter and return it to Synthes by either of the following methods: Mail provided postage paid envelope Fax 610-251-9005 Scan/e-mail to FieldAction@synthes.com For any questions call 1-800-420-7025 x5403 or contact their Synthes Spine Sales Consultant.