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Recall Observatory FDA recall evidence

Device product

Segmental fluted stem, 19x250mm bwd, Sterile, Rod, fixation, intramedullary and accessories- Specific Knee, Hip and Nail Implants

Z-2575-2017

February 28, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 76629
Status
Terminated
Classification
Class II
Quantity
9867
Official record key
device-enforcement:Z-2575-2017

Official wording

Reason: Zimmer Biomet Inc. initiated a field action on 02/28/2017 for sterile-packaged implants packaged in two different package configurations due to packaging design verification test failures.

Code information: Item Number: 00585205419, Lot Number Expiry Date Before: July 2026

Distribution pattern: Worldwide Distribution - US (nationwide) Foreign: Argentina, Australia, Belgium, Brazil, Bridgend Wales, Canada, Chile, Colombia, Dominican Republic, England, Eschbach, France, India, Italy, Japan, Jordan, Korea, Malaysia, Mexico, Netherlands, Nicaragua, Panama, Peru, Russia, Saudi Arabia, Singapore, Spain, Switzerland, Taiwan, Thailand

Derived failure modes

  • Device software or design

    reason.device_software_design · v1.0.0

    design verification test failures