Specialist 2 Intramedullary (SP2 IM) Rod 400mm Instrument (PN 96-6120) The SP2 IM Rod 400mm Instrument (PN 96-6120) is u

FDA device recall Z-0111-2016 · posted 2015-10-07 · Terminated

Recall details

Recalling firm

DePuy Orthopaedics, Inc.

Reason for recall

DePuy Orthopaedics, Inc. is initiating a voluntary recall of select lots of the Specialist 2 Intramedullary Rod 400mm Instrument (PN 96-6120) due to complaints of the rod fracturing and leaving a portion of the rod in patients.

Action taken

DePuy Synthes sent an Urgent Information Recall Notice to all affected customers. Instruments are not lot traceable in the system, so the company sent notices by e-mail on September 8, 2015, and US Distributors will hand deliver notices to all Medical Facilities that may have purchased the affected instrument. The US Distributor or US Sales Consultant will deliver the Medical Professional Notice and Reconciliation Form to the affected Medical Facilities. If assistance is needed, Sales Consultants will assist customers with inspection of all instruments, return of affected lots, receiving credit and returning the completed Medical Facility Reconciliation Forms to DePuy Orthopaedics, Inc. The affected instruments will be returned to the quarantine warehouse located at 700 Orthopaedic Drive, Warsaw, IN 46582. For questions regarding this recall call 574-371-4917. For questions regarding this recall call 574-267-8143.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

7488

Distribution

Worldwide Distribution - US including AL; AZ; CA; CO; CT; DC; FL; GA; HI; IA; IL; IN; KY; LA; MA; MD; ME; MI; MN; MO; MS; MT; NC; NE; NH; NJ; NV; NY; OH; OR; PA; RI; SC; TN; TX; UT; VA; VT; WA; WI; an

Date initiated

2015-09-08

Date posted

2015-10-07

Date terminated

2018-07-03

Location

Warsaw, IN