Skip to content
Recall Observatory FDA recall evidence

Device product

Humeral Guide Wire Ball Tip 2.4 mm Diameter 70 cm Length; Item Number: 47-2255-008-00

Z-1466-2018

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-1466-2018

Official wording

Reason: Potential failure of sterile packaging seal.

Code information: Lot Numbers: 63738593 63738594 63738595 63738596 63748395 63748396 63748397 63748398 63753767 63753768 63758425 63758428 63771163 77006530 77006531 77006532 77006533 77006534 77006535 77006536 77006537 77006538 77006539 77006540 77006541 77006542 77006543 77006544 77006545

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.