ClearanceBrief
Recall Z-0919-2020 ยท LXH Orthopedic Manual Surgical Instrument

Arthrex, Inc.

Arthrex Fibulock Fibular Nail Instrument Set Reusable non-sterile instruments Outrigger Targeting Guide

DateDec 17, 2019
StatusTerminated
ReasonThere is a potential for blockage of the Hub Attachment Tube.
Root causeProcess control
ActionConsignees were notified via e-mail with recall letter dated 12/17/2019. The letter identified affected product, reason for recall, and instructed consignee to immediately discontinue use, sale, and distribution of the product as well instructions for handling of affected product.
Quantity47
DistributionNationwide in US; no distribution OUS.
FDA recordOpen on fda.gov

510(k) clearances named in this recall

This recall record lists no 510(k) number.