DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 66mm GROUP H, REF DSBFGH66, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell.
FDA Recall Z-1026-2012 · Posted 2012-02-14
Recalling FirmWright Medical Technology Inc
Recall StatusTerminated
Product CodeKWA
Date Initiated2012-01-03
Date Terminated2013-03-13
Product Quantity68 units
Reason for Recall
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.
Firm 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.
Root Cause
Packaging
Distribution Pattern
Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Denmark, and Italy.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.