Recall Z-1992-2009 ยท MBF Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer, Uncemented
Encore Medical, Lp
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.
| Date | Sep 4, 2009 (initiated Jul 20, 2009) |
| Status | Terminated |
| Reason | 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 | 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 | 60 units |
| Distribution | Nationwide Distribution -- Including states of TX, FL, and GA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K081448 | ENCORE SHOULDER REVISION GLENOID Encore Medical L.P., Sep 30, 2008 |