Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041, All Lots. Product is a Shoulder Instrument used

FDA device recall Z-2636-2010 · posted 2010-09-30 · Terminated

Recall details

Recalling firm

Encore Medical, Lp

Reason for recall

Complaints indicate product's distal threaded tip may fracture under certain circumstances.

Action taken

DJO Surgical sent an "Urgent Field Safety Notice" Letter dated July 12, 2010, to all of their consignees. The letter described the product, the problem, and the action consignees should take. Consignees were instructed to: Contact their Customer Service Representative for an R-RPR (RMS) number and return all RSP Glenoid Head Inserters, 804-03-041, under the assigned number to receive credit. Complete and return the Field Safety Notice Response to the firm. Identify and inform any customers who were sold or received the product of the Field Safety Notice Any questions consignees should call the firm at (512) 834-6330.

Root cause

Device Design

Status

Terminated

Product code

LXH

Quantity affected

104

Distribution

Worldwide Distribution - USA, including the states of AR, AZ, CA, FL, GA, ID, IL, IN, LA, MA, ME, MI, MO, NM, NV, NY, OH, OK, PA, SC, TN, TX, UT, WA, and WI; and the countries of Puerto Rico, Germany,

Date initiated

2010-07-12

Date posted

2010-09-30

Date terminated

2011-06-30

Location

Austin, TX