Device Recall Stryker Orthopaedics Specialty Triathlon Tibial Alignment Handle with Secondary Lock 의 리콜

Recall

74619

Class 2

Z-2390-2016

2016-06-23

Terminated

United States

2018-08-01

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=148055

It was reported that the secondary locking mechanism, and its corresponding components, disassociated from the specialty triathlon tibial alignment handle with secondary lock assembly during surgery. upon further investigation, it was discovered that the weld, which was intended to hold the secondary locking mechanism together, did not meet the weld size specified on the engineering drawing.

Stryker sent an Urgent Product Recall letter dated June 24, 2016, with a Business Reply Form attached to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were asked to inform users of the Urgent Product Recall letter and forward the notice to all those individuals who need to be aware within their organization. Customers were instructed to return all affected product at their location to: Stryker C/O Stericycle 2670 Executive Dr., Suite A Indianapolis, IN 46241 Customers were also instructed to complete and sign the enclosed Business Reply Form and fax it to 888-912-7352 or email to Stericycle at strykerortho4582@stericycle.com. Customers with questions were advised to call (201) 831-6693. For questions regarding this recall call 201-831-5000.