Proven Porous CR Femur. Implantable orthopedic device
FDA Recall Z-0496-05 · Posted 2005-02-03
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Recalling FirmStelkast Co
Recall StatusTerminated
Product CodeJWH
Date Initiated2004-09-24
Date Terminated2005-02-07
Product Quantity105 units
Reason for Recall
Sterility may be compromised. The inner pouch of the implant packaging was sticking out beyond the seal of the outer pouch
Firm Action
The recalling firm telephoned their customers 9/24/04 to inform them of the problem and the need to return the product. As a follow up to the telephone call, the recalling firm sent fax notifications to their customers. The medical supply companies were instructed to contact their customers.
Root Cause
Other
Distribution Pattern
The product was shipped to medical supply companies in CA, MO, NC, and WV and sales representatives in AZ , NC and PA.
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.
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