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Recall Observatory FDA recall evidence

Device product

Zimmer Trabecular Metal Reverse Shoulder System Instrumentation, Drill 2.5 mm Diameter, Item Number/EDI 47430904601, Sterile

Z-3144-2017

May 22, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 77417
Status
Terminated
Classification
Class II
Quantity
2825 units
Official record key
device-enforcement:Z-3144-2017

Official wording

Reason: Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.

Code information: Lot Numbers: 63399406, 63399407, 63413258, 63418122, 63419454, 63421749, 63471169, 63471170, 63471171, 63474753, 63474754, 63484232, 63501370, 63633540, 63649266 & 63655091.

Distribution pattern: Nationwide in USA; Internationally to: Australia, Brazil, Canada, China, El Salvador, Germany, Guatemala, India, Japan, Panama, Malaysia, Mexico, Netherlands, South Korea, Singapore, Taiwan & Trinidad.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Various trauma and extremity instruments (drill bits and screw taps) were manufactured from raw material with an anomaly. The anomaly may be on or below the surface and can increase the risk of instrument fracture.