Recall Z-1030-2012
Wright Medical Technology Inc · initiated January 3, 2012
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.
Codes / lots: Lot Numbers: 0301028247, 0501034762, 0501078396
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.
FDA-determined 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.
Details
- Recall number
- Z-1030-2012
- Initiated
- January 3, 2012
- Posted by FDA
- February 14, 2012
- Terminated
- March 13, 2013
- Product code
- KWA – Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component)
- Quantity
- 7 units
- Distribution
- Worldwide Distribution-USA (nationwide) and the countries of Australia, Brazil, Canada, Denmark, and Italy.
- Recalling firm
- Wright Medical Technology Inc, Arlington, TN
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-1016-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 46mm GROUP B, REF DSBFGB46, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1017-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 48mm GROUP B, REF DSBFGB48, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1018-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 50mm GROUP C, REF DSBFGC50, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1019-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 52mm GROUP D, REF DSBFGD52, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1020-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 54mm GROUP E, REF DSBFGE54, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1021-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 56mm GROUP F, REF DSBFGF56, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1022-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 58mm GROUP G, REF DSBFGG58, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1023-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 60mm GROUP G, REF DSBFGG60, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1024-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 62mm GROUP G, REF DSBFGG62, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1025-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 64mm GROUP H, REF DSBFGH64, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1026-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 66mm GROUP H, REF DSBFGH66, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1027-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 68mm GROUP H, REF DSBFGH68, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1028-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 70mm GROUP J, REF DSBFGJ70, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1029-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 72mm GROUP J, REF DSBFGJ72, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |
| Z-1031-2012 | DYNASTY(R) BIOFOAM(R) SHELL, SIZE: 76mm GROUP K, REF DSBFGK76, Rx ONLY, STERILE R…The possibility exists that particulate debris from the packaging spacer could be unintentionally implanted… | 01/03/2012Terminated |