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Recall Observatory FDA recall evidence

Device product

CPT Modular Stem, Item No. 00-8011-001-00; Lot 61947708. CPT stems are primary cemented femoral hip stems used by surgeons in total hip arthroplasty.

Z-0060-2013

September 13, 2012

Class II

Product summary

Firm
Zimmer, Inc.
Event
Event 63124
Status
Terminated
Classification
Class II
Quantity
59 both units
Official record key
device-enforcement:Z-0060-2013

Official wording

Reason: Zimmer Inc. is initiating a removal of the CPT Modular Stem (item 00-8011-001-00), CPT Stem Petite (item 00-8011-000-05; ) and CPT Femoral Stem 12/14 Neck Taper Extended Offset,(item 00-8114-001-10 ) because devices were packaged in incorrect cartons and distributed internationally and domestically. Zimmer received five complaints of this packaging issue.

Code information: Lot 61947708

Distribution pattern: Worldwide Distribution-USA (nationwide) including the states of Indiana and Oklahoma and the countries of Australia, Thailand, Malaysia, Germany, India, Bulgaria, Egypt, UK, Russian FED, Slovak, and Brazil.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    packaging issue