DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 66mm GROUP H, REF DSBFGH66, Rx ONLY, STERILE R, Wright Medical Technology, Inc., hip
FDA device recall Z-1026-2012 · posted 2012-02-14 · Terminated
Recall details
- Recalling firm
- Wright Medical Technology Inc
- 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.
- 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.
- Root cause
- Packaging
- Status
- Terminated
- Product code
- KWA
- Quantity affected
- 68 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Denmark, and Italy.
- Date initiated
- 2012-01-03
- Date posted
- 2012-02-14
- Date terminated
- 2013-03-13
- Location
- Arlington, TN
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| DYNASTY POROUS ACETABULAR SHELL, DYNASTY POLYETHYLENE ACETABULAR LINER, DYNASTY METAL ACETABULAR LINER (K082924) | Wrightmedicaltechnologyinc | 2009-03-06 |