Z-2215-2008

Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1 each, Wright Medical Technology...

Name: Z-2215-2008 Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1 each, Wright Medical Technology...
Creator: Wright Medical Technology Inc
Published: 2008-05-20
License: https://open.fda.gov/license/

Wright Medical Technology Inc / initiated 2008-05-20 / Terminated

FDA source

Wright Medical Technology Inc began a recall of Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002... on 2008-05-20. The reason FDA records is "Trials are 2.5mm larger than marked". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2215-2008
Status: Terminated
Initiated: 2008-05-20
Posted: 2008-09-17
Terminated: 2009-01-25
Recalling firm: Wright Medical Technology Inc
Product: Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1 each, Wright Medical Technology, Inc., 5677 Airline, Road, Arlington, TN 38002 Orthopaedic instrument used for the preparation of the implant site prior to device implantation.
Product code: LXH Orthopedic Manual Surgical Instrument
Reason for recall: Trials are 2.5mm larger than marked.
FDA root cause: Component change control
Action: The firm initiated their recall on May 20, 2008 by issuing a Field Notice to their distributors and followed with telephone calls on May 21 and 22, 2008 requesting the return of the products. The firm then issued letters to their distributors on June 4, 2008 explaining the problem and requesting return of the product from their inventory and from their consignees. The letter included a "fax back" response page to ensure the receipt of the notice. The hospitals were notified of the recall also on June 4, 2008 by means of letters, delivered via Fed Ex, addressed to Hospital Administrators, Risk Managers, and Orthopaedic Department Managers.
Quantity in commerce: 128 units
Distribution: Worldwide Distribution --- including USA and Canada.
Product codes and lots: Lot Nos.: 037386983 and 117456822

Product code LXH

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)