Device Recall Synthes 2.4mm Titanium Locking Screws SelfTapping with Stardrive Recess 12mm 의 리콜

Recall

74719

Class 2

Z-2389-2016

2016-06-28

2016-08-11

Terminated

United States

2017-02-02

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148285

It was reported that the specified lots of the 2.4mm titanium locking screw self-tapping with stardrive recess 12mm can break between the head and the shaft. this resulted from the neck feature being too close to the stardrive feature leaving a thin wall between neck and drive.

The firm, DePuy Synthes, sent an "URGENT NOTICE: MEDICAL DEVICE RECALL" letter dated July 14, 2016 to affected customers. The letter described the product, problem and actions to be taken. The customers were instructed to review your inventory and immediately remove and return all unpackaged Locking Screws Self-Tapping with Stardrive Recess 12mm in any affected kits along with any screws still in the original packaging with the part number and lot number identified in the recall notification. Customers were also instructed to call DePuy Synthes at 1-800-479-6329 to obtain a Return Authorization (RA) Number, complete the Verification Section and indicate the number of devices found and return with product to: Credit/Returns, DePuy Synthes, 1101 Synthes Avenue, Monument, CO 80132 by fax to 877-523-9109 or scan/email: Synthes5246@stericycle.com, even if you do not have the product. 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. If you have any questions, please call 610-719-5450 or contact your DePuy Synthes Sales Consultant.