Skip to content
Recall Observatory FDA recall evidence

Device product

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.

Z-1317-2014

February 03, 2014

Class II

Product summary

Firm
Stryker Howmedica Osteonics Corp.
Event
Event 67734
Status
Terminated
Classification
Class II
Quantity
48 units
Official record key
device-enforcement:Z-1317-2014

Official wording

Reason: 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.

Code information: v40 Hip Stem -Right Size # 3: catalog # 6265-5113 lot code #43317101, v40 Hip Stem -Left Size # 4: catalog #6265-5104 lot code #43316801, lot code 43316901, v40 Hip Stem - Right Size #4: catalog #6265-5114 lot code #43113901

Distribution pattern: USA Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.