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Recall Observatory FDA recall evidence

Device product

M/DN Intramedullary Fixation Distal Drill Pilot Tip 3.2 mm Diameter, Item Number/EDI 00225503332, Nonsterile. orthopedic surgical instrument.

Z-3158-2017

May 22, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 77417
Status
Terminated
Classification
Class II
Quantity
182 units
Official record key
device-enforcement:Z-3158-2017

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: 63574676, 63574677, 63574678, 63424385, 63451742, 63493677 & 63493680

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.