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Recall Observatory FDA recall evidence

Device product

4.0/5.0mm Cannulated Screw System, BCS Cannulated Screw System (3.0, 4.0/5.0, 6.5/8.0mm), Item numbers 110009810, 110009821, 110009825, 110009852 - Product Usage: Fracture fixationof small bones, small bone fragements and long bones.

Z-0617-2021

November 25, 2020

Class II

Product summary

Firm
Biomet, Inc.
Event
Event 86896
Status
Terminated
Classification
Class II
Quantity
N/A
Official record key
device-enforcement:Z-0617-2021

Official wording

Reason: Specific lots of multiple sterile medical devices may have a breach in the sterile seal. A breach in the packaging seal could lead to loss of sterility of the device.

Code information: Lots 180720 334220 285750 285760

Distribution pattern: Worldwide distribution. US nationwide, ARGENTINA, AUSTRALIA, Brazil, CANADA, CHILE, CHINA, COSTA RICA, EMEA, HONG KONG, INDIA, JAPAN, KOREA, MALAYSIA, NEW ZEALAND, SINGAPORE, and TAIWAN

Derived failure modes

  • Sterility assurance

    reason.sterility_assurance · v1.0.0

    loss of sterility