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Recall Observatory FDA recall evidence

Device product

Zimmer Natural Nail System Tear Drop Guide Wire 2.4 mm Diameter, 70 cm length, Item Number 47-2490-098-01 Product Usage: The Ball Tip and Tear Drop Guide Wires are used during the initial reaming of the intramedullary canal. They also assists in guiding the nail during implantation. The guide wire incorporates either a ball or tapered tip to aid in removal of the intramedullary reamer if it becomes lodged or fails.

Z-0551-2018

June 05, 2017

Class II

Product summary

Firm
Zimmer Biomet, Inc.
Event
Event 78219
Status
Terminated
Classification
Class II
Quantity
1,631 units
Official record key
device-enforcement:Z-0551-2018

Official wording

Reason: The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.

Code information: All Lot Numbers Expiry Date Before March 2022

Distribution pattern: Nationwide within U.S.A and Puerto Rico; International: Australia, Brazil, Canada, China, Germany, India, Japan, Netherlands & Singapore

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    The design verification for the previous packaging configuration G928 does not cover the 70cm wires. A design verification has been completed to move the 70cm guide wires to a new packaging configuration. As a result, the products packaged in the previous packaging configuration are being removed.