Recall of Device Recall 2.5 mm Reaming Rod, Ball tip, 950 mm, sterile

Recall

79157

Class 2

Z-0901-2018

2017-07-26

Open, Classified

United States

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=161453

Possible lack of product sterility due to potential gaps/channeling in the seal of the package.

The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 7/26/2017 to its customers. The letter described the product, problem, and actions to be taken. The customers were instructed to do the following: If you DO have any of the identified devices and intend to re-sterilize the product (TRAUMA Products only) per the package insert, please take the following steps: ¿ Complete the Verification Section at the end of this letter by checking the appropriate box indicating affected product has been located and will be re-sterilized. Also, please indicate the number of devices found. Please include your name, title, telephone number and signature in the spaces provided. ¿ Send a copy of the completed Verification Section to Synthes by: o Fax: 844-721-3045 or o Scan/email: Synthes5735@stericycle.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clearly indicate the name and address of the facility and/or individual on page 4 of the notification. If you DO have any of the identified devices, and are returning the product for replacement, please take the following steps: ¿ Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number. ¿ Complete the Verification Section (page 4 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, address, telephone number and signature in the spaces provided. ¿ Return the Verification Section (page 4 of this letter) with the product to: o Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. ¿ Send a copy of the completed Verification Section to Synthes by: o Fax: 844-721-3045 or o Scan/email: Synthes5735@stericycle.com Note: If the Verification Section is answered on behalf of more than one facility and/or individual, please clea