Recall Z-2789-2016 ยท MBH Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Stryker Howmedica Osteonics Corp.
Stryker Orthopaedics Patella Assembly Instrument, REF 3182-1000, Non-Sterile, NDC (01) 07613327215854 (10) The Scorpio Patella Assembly Instrument is used during total knee replacement surgery for the implantation of Scorpio Patella implant components. The device functions to fully seat the implant onto the bone and secure it in position while the surgeon removes any excess cement and when cement
| Date | Sep 13, 2016 (initiated Aug 1, 2016) |
| Status | Terminated |
| Reason | Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument. |
| Root cause | Nonconforming Material/Component |
| Action | Stryker sent an "Urgent Medical Device Recall Notification" Letter and Recall Business Reply Form dated August 1, 2016 to their affected customers via email and also via UPS on August 1, 2016. Customers are asked to quarantine the product subject to this recall. Branches/Agencies are asked to return all affected products available at their location to: Stryker C/O Stericycle, Attn: RA 2016-098 - Event 8296. Hospital/Branches: Customers are asked to complete and sign the Business Reply Form and fax a copy within 5 business days to: 877-272-6141 or email to Stericycle strykerortho8296@stericy |
| Quantity | 2,039 units |
| Distribution | US Nationwide and Internationally |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K033972 | SCORPIO TOTAL KNEE SYSTEM Howmedica Osteonics Corp., Apr 12, 2004 |