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Terminated

Stryker Orthopaedics Scorpio femoral component. Howmedica Osteonics Corp., A subsidiary of Stryker Corporation Made in USA Sterile. For use in total reconstructive replacement of the knee joint.

FDA Recall Z-1634-2015 · Posted 2015-05-19

Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeJWH
Date Initiated2014-08-15
Date Terminated2018-01-05
Product Quantity1,147 in total

Reason for Recall

The peel strength of the inner blister may have been below internal validated requirements. The strength of the seal is directly related to long term shelf life of the sterile barrier.

Firm Action

The firm, Stryker Orthopaedics, notified their Branches/Agencies via email on 8/15/2014 and sent an "Urgent Product Recall" letter dated 8/15/2014 with a Product Recall Acknowledgement Forms to their Branches/Agencies and consignees. The letter describes the product, issue, potential hazards and actions to be taken. The consignees were instructed to complete and return the attached Product Recall Acknowledgment Form within 5 days via fax to 855-251-3635; and return the affected product to the attention of Regulatory Compliance, Stryker Orthopaedics, 325 Corporate Drive, Mahwah NJ 07430. If you have any questions, feel free to contact Sr. Regulatory Compliance Specialist to 201-831-5826.

Root Cause

Under Investigation by firm

Distribution Pattern

Worldwide Distribution: US (nationwide) including PR and countries of: Australia, Canada, China, Brazil, France, Hong Kong, India, Italy, Mexico, Netherlands, Singapore, South Africa, Sweden, and Spain.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K042343SCORPIO NRG KNEE SYSTEMHowmedica Osteonics Corp. · 2005-02-09K030978SCORPIO NRG KNEE SYSTEMHowmedica Osteonics Corp. · 2003-11-20K974556OSTEONICS SCORPIO POSTERIOR CRUCIATE RETAINING TOTAL KNEE SYSTEMOsteonics Corp. · 1998-02-27K962152OSTEONICS SCORPIO POSTERIORLY STABILIZED TOTAL KNEE SYSTEMOsteonics Corp. · 1996-08-14

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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