Scorpio/ NRG 4in1 Cutting Block The Scorpio total knee system is indicated for primary Total knee Arthoplasty (TKA) proc

FDA device recall Z-0050-2011 · 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