DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 46mm GROUP B, REF DSBFGB46, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip prosthesis acetabular component. The instrument is used as a hip acetabular shell.
- Company
- Wright Medical Technology Inc
- Recall Initiated
- January 3, 2012
- Posted
- February 14, 2012
- Terminated
- March 13, 2013
- Recall Number
- Z-1016-2012
- Quantity
- 160 units
- Firm Location
- Arlington, TN
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.
Distribution
Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Denmark, and Italy.
Lot / Code Info
Lot Numbers: 069846528, 119925740, 010970893, 020998825, 079853470, 79859628, 079868615, 089870267, 089875761, 089878278, 099890880, 099907005, 109917381, 109921935, 119925740, 119930199, 129937584, 0201014640, 0311295429, 0401072697, 0501102202, 0611368642, 0711367603, 0711367604, 0801144244, 0801150043, 0901165305, 04189088001, 04193758401, 04198097901, 05983919310, 05984293410, 06984652810
Root Cause
Packaging
Action Taken
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.