Synthes Titanium Small Reconstruction Plate 의 리콜

Recall

72407

Class 2

Z-0236-2016

2015-10-08

2015-11-06

Terminated

United States

2016-07-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140958

The synthes sntrp set was released for sale as a trauma product in 1996 with specific trauma indications and contraindicated for certain spine applications. in 1999, a module was released containing a small offering of the sntrp plates. synthes determined that the product in the sntrp module is being used in spine surgeries, which are a contraindicated use.

Synthes sent an Urgent Notice Medical Device Letter dated October 8, 2015. to all affected customer. The letter identified the product the problem and the action needed to be taken by the customer. Please take the following actions: If you DO have any of the identified devices, please take the following steps: "Call Synthes at 1-800-479-6329 to obtain a Return Authorization Number. "Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located. Also, please indicate the number of devices found and note the Return Authorization Number. Please include your name, title, telephone number, and signature in the spaces provided. "Return the Verification Form (page 3 of this letter) If you DO NOT have the identified product, please take the following steps: "Complete the attached Verification Section at the end of this letter by checking the appropriate box indicating that no affected product has been located. Please include your name, title, telephone number, and signature in the spaces provided. This return documentation acknowledges your receipt of medical device removal information. "Return the documents to Synthes by: "Fax: (866) 240-5364 or "Scan/email: Synthes4642@stericycle.com If you have any questions, please call 610-719-5450 or contact your Synthes Sales Consultant. Thank you for your attention to this issue.