Citation TMZF HA 132 degrees Neck Angle, V40 Hip Stem - Right Size #3: catalog # 6265-5113 , Left Size #4: catalog #6265-5104 , and Right Size #4: catalog #6265-5114; Stryker Howmedica Osteonics Hip Implants.
FDA Recall Z-1317-2014 · Posted 2014-04-02
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Recalling FirmStryker Howmedica Osteonics Corp.
Recall StatusTerminated
Product CodeMEH
Date Initiated2014-02-03
Date Terminated2014-12-02
Product Quantity48 units
Reason for Recall
Stryker received a report from the field indicating that a citation TMZF HA 132 degrees neck angle V40 Hip Stem - Left Size # 4
was identified in a packaging associated with a citation TMZF HA 132 degrees Neck Angle V40 Hip Stem - Right Size #3.
Firm Action
Stryker sent an Urgent Medical Device Recall Notification letters and Product Accountability Forms to Hospital Risk Management, Chief of Orthopaedics, and Surgeons via Fed Ex with return receipt on February 26, 2014. The letter identified the affected product, problem and actions to be taken. Customer were instructed to return the affected product to the attention of Regulatory Compliance. Please attach the fluorescent orange PRODUCT REMEDIATION sticker to your return. For questions call 201-972-2100.
Root Cause
Error in labeling
Distribution Pattern
USA Nationwide Distribution
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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