Stryker Orthopaedics Triathlon 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-1635-2015 · Posted 2015-05-19
Advertisement
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.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
Advertisement