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Recall Observatory FDA recall evidence

Device product

Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length; Item Number: 47-2490-098-01

Z-1468-2018

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-1468-2018

Official wording

Reason: Potential failure of sterile packaging seal.

Code information: Lot Numbers: 63733044 63748390 63748391 77006546 77006547 77006548

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.