Z-2636-2010

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

Name: Z-2636-2010 Glenoid Head Inserter (RSP Inserter/Impactor), Device Part #804-03-041, All Lots. Product is a Shoulder...
Creator: Encore Medical, Lp
Published: 2010-07-12
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2010-07-12 / Terminated / root cause: design

FDA source

Encore Medical, Lp began a recall of 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... on 2010-07-12. The reason FDA records is "Complaints indicate product's distal threaded tip may fracture under certain circumstances". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as design.

Recall record

Recall number: Z-2636-2010
Status: Terminated
Initiated: 2010-07-12
Posted: 2010-09-30
Terminated: 2011-06-30
Recalling firm: Encore Medical, LP
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
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Complaints indicate product's distal threaded tip may fracture under certain circumstances.
Root cause tag: design
FDA root cause: 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.
Product codes and lots: Device Part #804-03-041, All Lots.

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)