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U.S. Department of Health and Human Services

Class 2 Device Recall Glenoid Head Inserter (RSP Inserter/Impactor)

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 Class 2 Recall
Glenoid Head Inserter (RSP Inserter/Impactor)
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Date Posted September 30, 2010
Recall Status1 Terminated on June 30, 2011
Recall Number Z-2636-2010
Recall Event ID 56220
Product Classification Orthopedic Manual Surgical Instrument - Product Code LXH
Product 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
Code Information Device Part #804-03-041, All Lots.
Recalling Firm/
Encore Medical, Lp
9800 Metric Blvd
Austin, Texas 78758
Manufacturer Reason
for Recall
Complaints indicate product's distal threaded tip may fracture under certain circumstances.
FDA Determined
Cause 2
DESIGN: Device Design
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.
Quantity in Commerce 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, and Saudi Arabia.
Total Product Life Cycle TPLC Device Report

1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.