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.
FDA Recall Z-2789-2016 · Posted 2016-09-13
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMBH
Date Initiated2016-08-01
Date Terminated2017-06-08
Product Quantity2,039 units
Reason for Recall
Upon failure of the press-fit, the clamping sub components and pins could disassociate from the Scorpio Patella Assembly Instrument.
Firm 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 [email protected]. Any questions, customers can call (201) 831-6693.
Root Cause
Nonconforming Material/Component
Distribution Pattern
US Nationwide and Internationally
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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