FDA Medical Device Recalls (openFDA)
Wright Medical Technology Inc: 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.
- Recall number
- Z-2215-2008
- 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.
- Status
- Terminated
- Initiated
- 2008-05-20
- Posted
- 2008-09-17
- Terminated
- 2009-01-25
- Reason
- Trials are 2.5mm larger than marked.
- 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
- 128 units
- Distribution
- Worldwide Distribution --- including USA and Canada.
- Lot, serial or model codes
- Lot Nos.: 037386983 and 117456822
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LXH
- Firm FEI
- 1043534
- Firm city
- Arlington
- Firm state
- TN
- 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