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.
FDA Recall Z-1992-2009 · Posted 2009-09-04
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Recalling FirmEncore Medical, Lp
Recall StatusTerminated
Product CodeMBF
Date Initiated2009-07-20
Date Terminated2010-01-07
Product Quantity60 units
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.
Firm 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.
Root Cause
Release of Material/Component prior to receiving test results
Distribution Pattern
Nationwide Distribution -- Including states of TX, FL, and GA.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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