Periarticular Insertion Handle and Periarticular Aiming Arm for 4.5mm LCP Proximal Tibia Plates 의 리콜

Recall

72238

Class 2

Z-0024-2016

2015-09-14

2015-10-05

Terminated

United States

2016-07-15

USFDA

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=140316

Affected lots of periarticular aiming arms and insertion handles (part numbers 03.120.001, 03.120.002, 03.120.004 and 03.120.005) for the 4.5 mm lcp proximal tibia plates are not able to be secured to the subsequent versions of these devices as intended.

An urgent notice of medical device recall, dated September 14, 2015, was sent to end users and sales consultants to alert them to the issue and potential risks. Return of the completed response form and the affected devide was also requested.