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Recall Observatory FDA recall evidence

Device product

fastener, fixation, nondegradable, soft tissue

Z-1009-2018

October 25, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 79273
Status
Terminated
Classification
Class II
Quantity
429 units
Official record key
device-enforcement:Z-1009-2018

Official wording

Reason: It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.

Code information: Item # 110019010 Lot #'s 017350 141990 142000 142020 167190 240720 240740 240770 257970 398710 398730 398740 398750 421780 421790 421800 465910 504120 813190 940370

Distribution pattern: TX, NC, FL, PA, IN, WI, VA, NY, NJ, AL, CT

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    It was identified that the product was not assembled correctly causing the implant shaft to shift and fall out during the opening of the device, which potentially could break the device.