Synthes Threaded Plate Holder Long for 3.5mm Locking Hold 의 리콜

Recall

72360

Class 2

Z-0192-2016

2015-10-07

Terminated

United States

2016-08-26

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140745

The affected part number and lot listed above is incorrectly etched with the wrong part number and may not fit into a small fragment plate.

The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated 10/5/2015 to its customers. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: " Call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number and replacement product(s). " Complete the Verification Section (page 3 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 3 of this letter) with the product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132. Even if you do not have any product. " Send a copy of the completed Verification Section by: Fax: 844-721-3048 or Scan/email: Synthes4704@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 3 of the notification. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.