Turon Revision Glenoid Poly Liner. The Metal Backed Revision Glenoid is a two piece metal backed polyethylene glenoid co
FDA device recall Z-1992-2009 · posted 2009-09-04 · Terminated
Recall details
- Recalling firm
- Encore Medical, Lp
- 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.
- Action taken
- 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
- Status
- Terminated
- Product code
- MBF
- Quantity affected
- 60 units
- Distribution
- Nationwide Distribution -- Including states of TX, FL, and GA.
- Date initiated
- 2009-07-20
- Date posted
- 2009-09-04
- Date terminated
- 2010-01-07
- Location
- Austin, TX
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| ENCORE SHOULDER REVISION GLENOID (K081448) | Encore Medical L.P. | 2008-09-30 |