Recall Z-0930-2012 ยท HWA Impactor
DePuy Orthopaedics, Inc.
The SIGMA HP Fixed Bearing Tibial Tray Impactor is part of a set of tools designed specifically for the installation of the PFC SIGMA Knee. SIGMA HP Fixed Bearing Tibial Tray Impactors Packaged in poly bag with optional protection from sharp or fragile points, distributed by DePuy International Leeds, UK. Instruments are supplied non-sterile and do not have specified expiration date or shelf life
| Date | Jan 30, 2012 (initiated Dec 13, 2011) |
| Status | Terminated |
| Reason | All lots of DePuy, SIGMA HP Fixed Bearing Tibial Tray Impactors are being recalled because the impactor can become intentionally locked on the Tibial Tray implant during surgery. |
| Root cause | Device Design |
| Action | The firm, DePuy, sent an "URGENT INFORMATION - MEDICAL DEVICE RECALL NOTICE" email dated December 13, 2011 to its customers. The email notice described the product, problem and actions to be taken. The customers were instructed to cease use or distribution of recalled products and to return them to DePuy in Warsaw, IN; follow the instructions provided and complete and return the Fax Back Response card via fax to: 574-372-7567 or email: kseppa@its.jnj.com by December 23, 2011. For questions about recall information provided, please contact Manager of Customer Quality at 574-372-7333 (M-F; 8 a |
| Quantity | 1794 |
| Distribution | Worldwide distribution: USA (nationwide) and countries of: Canada, Ireland and South Africa. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.