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Recall Observatory FDA recall evidence

Device product

ZMS Intramedullary Fixation Smooth Guide Wire 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-037-00

Z-1470-2018

March 26, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 79681
Status
Terminated
Classification
Class II
Quantity
19483 total products
Official record key
device-enforcement:Z-1470-2018

Official wording

Reason: Potential failure of sterile packaging seal.

Code information: Lot Numbers: 63662549 63668704 63696974 63709171 63721377 63731176 63764550 63771164 63781920 63803595 63812302 63817719 63826242

Distribution pattern: US Nationwide and the following countries: Brazil, Singapore, Canada, Australia, Japan, Malaysia, Chile, Netherlands, Trinidad

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Potential failure of sterile packaging seal.