FDA Medical Device Recalls (openFDA)
Wright Medical Technology Inc: DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 74mm GROUP J, REF DSBFGJ74, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell.
- Recall number
- Z-1030-2012
- Recalling firm
- Wright Medical Technology Inc
- Product
- DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 74mm GROUP J, REF DSBFGJ74, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell.
- Status
- Terminated
- Initiated
- 2012-01-03
- Posted
- 2012-02-14
- Terminated
- 2013-03-13
- Reason
- The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted into a patient and could potentially lead to complications that might necessitate a revision surgery.
- Root cause
- Packaging
- Action
- Wright Medical sent an "URGENT PRODUCT RECALL NOTIFICATION" letter dated December 27, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to check their inventory for the affected product and to return any affected product to the firm. A Product Recall Verification Form was enclosed for customers to complete and return via fax to 901-867-7401. Contact Customer Service at 1-800-238-7117 for questions regarding this recall.
- Quantity
- 7 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Denmark, and Italy.
- Lot, serial or model codes
- Lot Numbers: 0301028247, 0501034762, 0501078396
- 510(k) numbers
- ["K082924"]
- PMA numbers
- not on file
- Product code
- KWA
- 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
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
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