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Terminated

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

FDA Recall Z-2636-2010 · Posted 2010-09-30

Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeLXH
Date Initiated2010-07-12
Date Terminated2011-06-30
Product Quantity104

Reason for Recall

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

Firm Action

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

Distribution Pattern

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, and Saudi Arabia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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