Scorpio/ NRG 4 in1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) pro
FDA device recall Z-0051-2011 · posted 2010-10-13 · Terminated
Recall details
- Recalling firm
- Stryker Howmedica Osteonics Corp.
- Reason for recall
- Stryker s has received reports in which the Cutting Blocks have fractured on impaction during surgery.
- Action taken
- 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.
- Root cause
- Device Design
- Status
- Terminated
- Product code
- LXH
- Quantity affected
- 839 (total)
- Distribution
- Worldwide distribution: USA and countries including: Asia, Canada, Europe, Middle East and Africa
- Date initiated
- 2010-08-23
- Date posted
- 2010-10-13
- Date terminated
- 2012-08-30
- Location
- Mahwah, NJ
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