Z-1992-2009

Turon Revision Glenoid Poly Liner. The Metal Backed Revision Glenoid is a two piece metal backed polyethylene...

Name: Z-1992-2009 Turon Revision Glenoid Poly Liner. The Metal Backed Revision Glenoid is a two piece metal backed polyethylene...
Creator: Encore Medical, Lp
Published: 2009-07-20
License: https://open.fda.gov/license/

Encore Medical, LP / initiated 2009-07-20 / Terminated / root cause: manufacturing process

FDA source

Encore Medical, Lp began a recall of Turon Revision Glenoid Poly Liner. The Metal Backed Revision Glenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder... on 2009-07-20. The reason FDA records is "Product devices used for testing are not identical to what was manufactured. Under certain circumstances snap feature could allow poly liner to move on baseplate reducing tightness of fit". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-1992-2009
Status: Terminated
Initiated: 2009-07-20
Posted: 2009-09-04
Terminated: 2010-01-07
Recalling firm: Encore Medical, LP
Product: Turon Revision Glenoid Poly Liner. The Metal Backed Revision Glenoid is a two piece metal backed polyethylene glenoid component for use in total shoulder arthroplasty. It includes a metal baseplate and polyethylene liner. DJO Surgical shoulder devices are intended for treatment of patients who are candidates for shoulder arthroplasty per the indications for use.
Product code: MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Reason for recall: Product devices used for testing are not identical to what was manufactured. Under certain circumstances snap feature could allow poly liner to move on baseplate reducing tightness of fit.
Root cause tag: manufacturing process
FDA root cause: Release of Material/Component prior to receiving test results
Action: Firm notified consignees by an Urgent: Medical Device Recall letter, dated July 20, 2009. The letter stated the reason for the recall, asked customers to quarantine, and return the affected product. The enclosed response form needed to be completed and returned as soon as possible. Questions were to be directed to David Harris, Manager of Customer Service at 512-834-6330.
Quantity in commerce: 60 units
Distribution: Nationwide Distribution -- Including states of TX, FL, and GA.
Product codes and lots: Lot numbers: 53987943, 53987944, 53987945, 53987946, and 53987947.

Product code MBF

K081448Class IIEncore Shoulder Revision GlenoidEncore Medical L.P. / cleared 2008-09-30

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)