FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1992-2009
- 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.
- Status
- Terminated
- Initiated
- 2009-07-20
- Posted
- 2009-09-04
- Terminated
- 2010-01-07
- 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.
- Lot, serial or model codes
- Lot numbers: 53987943, 53987944, 53987945, 53987946, and 53987947.
- 510(k) numbers
- ["K081448"]
- PMA numbers
- not on file
- Product code
- MBF
- Firm FEI
- 1000116912
- Firm city
- Austin
- Firm state
- TX
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28