Recall Z-0052-2011 ยท LXH Orthopedic Manual Surgical Instrument
Stryker Howmedica Osteonics Corp.
Scorpio/ NRG 4 i n1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) procedures. The Scorpio Femoral Component is implanted on femur after making bone cuts to accommodate the shape of the implant. The Scorpio instrumentation includes a 4 in 1 Cutting block 98010-00xx) which serves as a guide to allow the surgeon to make the bone e cuts necessary for
| Date | Oct 13, 2010 (initiated Aug 23, 2010) |
| Status | Terminated |
| Reason | Stryker s has received reports in which the Cutting Blocks have fractured on impaction during surgery. |
| Root cause | Device Design |
| Action | Stryker Orthopaedics sent an "URGENT PRODUCT RECALL" letter dated August 30, 2010, to all consignees/customers (branches/agencies, hospital risk management, hospital Chief of Orthopaedics, surgery) including foreign countries. The letter described the product, problem, and action to be taken by customers. The customers were instructed to complete and return the attached PRODUCT RECALL ACKNOWLEDGMENT FORM via fax to 201-831-6069. If you have any questions, feel free to contact the Manager, Divisional Regulatory Compliance (201) 972-2100. |
| Quantity | 839 (total) |
| Distribution | Worldwide distribution: USA and countries including: Asia, Canada, Europe, Middle East and Africa |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.