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Recall Observatory FDA recall evidence

Device product

Zimmer Natural Nail System Tear Drop Guide Wire 3.0 mm Diameter, 70 cm length; Item Number: 47-2490-098-00

Z-1467-2018

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-1467-2018

Official wording

Reason: Potential failure of sterile packaging seal.

Code information: Lot Numbers: 63631729 63638177 63645647 63645648 63662542 63681727 63690177 63690178 63733040 63733041 63733042 63748389 63753764 63758424 63771141 63780123 63787478 63826236 77006549 77006550 77006551 77006553 77006558 63836288

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.