Hipstar TMZF Cementless Hip Stem Protocol, Product Number: LSP60.
FDA Recall Z-0475-2008 · Posted 2007-12-14
Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeLPH
Date Initiated2007-09-28
Date Terminated2008-09-05
Product Quantity192 protocols
Reason for Recall
Mis-labeling: An error on page 4 of the Hipstar protocol was found. In the table for compatible Heads, the 40 mm diameter heads with a Neck Length of +12 should have been omitted.
Firm Action
Urgent Product Correction Letters, dated 10/17/2007 were sent on 10/17/07by Federal Express to all Stryker Branches/Agencies who had received the protocol. The branches were instructed to quarantine and destroy the protocols.
Root Cause
Other
Distribution Pattern
Nationwide:The protocol was distributed to 9 Stryker branches/agencies in NJ, MD, IN, MI, MN, IL and TX.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.