Skip to content
Recall Observatory FDA recall evidence

Device product

ZMS Intramedullary Fixation Smooth Guide Wire Bullet Tip 3.0 mm Diameter, 100 cm Length; Item Number: 47-2237-038-00

Z-1476-2018

March 26, 2018

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 79681
Status
Terminated
Classification
Class II
Quantity
19,483 total products
Official record key
device-enforcement:Z-1476-2018

Official wording

Reason: Potential failure of sterile packaging seal.

Code information: Lot Numbers: 63645655 63650115 63650116 63655995 63655996 63655997 63655998

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.