Recall Z-2789-2016— Stryker Howmedica Osteonics Corp.
Class II · Terminated
Class II FDA medical device recall by Stryker Howmedica Osteonics Corp., initiated 2016-08-01, terminated 2017-06-08. It names one FDA 510(k) clearance: K033972. Product: 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 polymerization occurs.. Reason: Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument..
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2016-08-01
- Terminated
- 2017-06-08
- Firm location
- Mahwah, NJ, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 polymerization occurs.
Reason for recall
Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.
Data sourced from openFDA. This site is unofficial and independent of the FDA.